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Advanced Scientifics Advanced Scientifics, Inc. is an ISO 13485:2003 certified, FDA registered contract manufacturer of Class I and II disposable medical devices. The company specializes in fluid management and drug delivery devices. Advanced Scientifics, Inc. provides complete manufacturing services including design, clean room injection molding, clean room film conversion, clean room assembly and clean room packaging. All of this is performed to a customer’s specification. Finally, Advanced Scientifics, Inc. manages the sterilization and related validation of the product. Web: www.advancedscientifics.com |
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Analogic Corporation Analogic Corporation is a leading-edge developer, designer, and manufacturer of OEM and end-user medical instrument systems, subsystems and accessories – with 40 years' experience in the medical instrumentation field. Our OEMs have relied on our expertise for all facets of product development, ranging from initial designs and prototyping to validation, regulatory approval guidance, and turnkey manufacturing. Our expertise in signal acquisition, processing algorithms, user interfaces, and hardware design is second to none. Web: www.analogic.com |
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ARMM, Inc. ARMM Inc. is a full service contract manufacturer providing services for the designing, packagin, blister sealing, filling, pouch sealing, assembling, ultrasonic welding, and laser marking of plastic components for medical devices. Products can be sterilized after processing in cleanrooms following Good Manufacturing Practices (QSR). ISO 13485 certified. Web: www.armminc.com |
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Aubrey Group, Inc. Aubrey Group, Inc. in Irvine, CA specializes in design and manufacture of electromechanical medical devices. Services include system and electronic engineering, software and mechanical engineering, V&V, compliance testing, prototypes and manufacturing. Specialties include RF generators, wireless, fluidics, implantables, blood separation and pumping. The company is FDA-registered and ISO 13485 certified. Web: www.aubreygroup.com |
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B Braun OEM, B. Braun Medical Inc. B. Braun OEM Division designs and manufactures a variety of class II and III medical devices for the pharmaceutical, biotech and surgical markets, including fluid administration systems, components and custom kits. OEM/Industrial takes customers’ designs from the earliest stages through design prototyping, assembly, packaging and sterilization. The B. Braun OEM Division of B. Braun Medical Inc. is based in Bethlehem, PA Web: www.bbraunoem.com |
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Beahm Designs, Inc. Thermal Traverser (410A) Provides Hands-Free lamination solution for short to medium lengths. This system traverses a multi-port thermal nozzle along a specified length to laminate or weld a catheter shaft. An easy to use motion control keypad allows the user to input precise length, speed and temperature values. A wide range of customizable options are available including product tensioning and clamping. Web: www.beahmdesigns.com |
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Camstar Systems Camstar’s Medical Device Suite provides real-time visibility into manufacturing, enforces quality at every step of the manufacturing process, and provides a complete, fully traceable as-built history. Discover why the world’s top medical device companies trust Camstar to help them reduce cycle times, improve quality, reduce risk and simplify regulatory compliance. Web: www.camstar.com |
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Creganna Medical Devices Creganna Medical Devices provides catheter shaft components, sub assemblies and design in a range of metals, polymers and composite materials. Creganna is a leading supplier to the world’s largest minimally invasive medical device companies. Manufacturing facilities are based in Massachusetts and Galway, Ireland, with sales facilities in California, Minnesota and Finland. Web: www.creganna.com |
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Criterion Instrument FDA registered precision machine shop supports biotech/bio-med and medical device companies by manufacturing prototype components for development, testing, proof of concept and clinical trials. Our core competencies also include the machining of medical instruments, implants and diagnostic instrumentation. Visit www.criteriontool.com to view samples of expertise in CNC Milling, Turning and Swiss Turning. Criterion is certified to ISO 9001:2000 by CRS Registrars. Web: www.criteriontool.com |
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Donatelle Donatelle is an FDA compliant, ISO-9001:2000 and ISO-13485:2003 certified supplier with expertise in molding engineering grade thermoplastic and elastomeric materials, micro molding, and liquid silicone injection molding. Our diverse list of capabilities includes: complete design and engineering services, a dedicated R&D and rapid prototyping department, in-house CAD/CAM based tooling design and fabrication, insert molding, overmolding, white room molding, Class 100,000 and 10,000 clean room assembly. In addition, we offer extensive contract manufacturing services that include: assembly, machining, welding, decorating, packaging, and sterilization management. Web: www.donatelle.net |
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Dunn Industries For over twenty years, Dunn has specialized in extrusion for the medical, telecom and aerospace industries. We’re able to satisfy the exacting quality standards required by these industries thanks to the experience and expertise of our team. We continue to innovate as specifications get tighter, dimensions get smaller and materials evolve. Our customers value our ability to deliver solutions and appreciate the straight forward way we do business. Web: www.dunnindustries.com |
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Eagle Stainless Tube & Fabrication Primary Source for Stainless Steel Products ISO 9001:2000 and AS 9000 certified. This 30 page guidebook offers up-to-date technical information. Machining, Welding, Cutting, Assemblies, Bending – we do it all. Celebrating 25 years serving medical, aerospace and high tech industries. A pdf version is viewable on our website. Web: www.eagletube.com |
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EtQ Solutions EtQ Reliance for Medical Device is an integrated quality and FDA compliance management system that has been pre-configured to specifically address the needs of the Medical Device industry. EtQ’s modules are tightly integrated to deliver a best-in-class FDA compliance solution. Modules include CAPA, Compliant Handling, Risk Assessment, Nonconforming Materials, Document Control, Audits, Centralized Reporting and more. Web: www.etq.com |
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Everite BURR FREE CUTOFF and GRINDING True burr free cutoff and grinding are easily obtained on any of Everite Machine Products unique line of Electrochemical tube cutoff machines and surface grinders. By combining the stress free principles of electrochemical dissolution of metals with the precision of abrasive grinding, fast, clean, accurate and burr free cuts are now routine. Web: www.everite.net |
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ExtruMed, Inc. ExtruMed is an ISO registered manufacturer of high precision extruded tubing for use in medical applications. ExtruMed was founded in 1990 to serve the OEM’s needs for quick turn custom extrusions. Dedication to high quality and customer service has led to ExtruMed becoming a critical supplier to both large and small medical device manufacturers. The major markets that our tubing are utilized in include: Cardiac Rhythm Management, Neuro-stimulation, Endoscopy, Laparoscopy, and Endovascular. Web: www.extrumed.com |
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Filtrona Extrusion, Inc. Filtrona Extrusion’s Medical Division offers precision thermoplastic extrusions produced in pyrogen-controlled Class 100,000 clean rooms. ISO 9001-2000 and ISO 14001 certified, capabilities include: SPC documentation, on-line measurement, in-house wire EDM Cad/Cam system, multi-lumen tubing, reinforced high-pressure tubing, co- and tri-extrusions, thermo-bonding, custom profiles, secondary operations and sub-assembly. Web: www.filtronaextrusion.com |
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Gauthier Biomedical Gauthier Biomedical’s extensive background in biomedical engineering and orthopedics is a driving force in their pursuit to provide the highest-quality tools in the handheld orthopedic and spinal instrumentation market. Their wide-ranging background in customizing instruments assures that they are the most competent instrumentation source in the industry. Gauthier Biomedical offers a comprehensive line of spinal and orthopedic instruments and production contract manufacturing services to Orthopedic OEMs in the U.S., Europe and Asia. Gauthier Biomedical is FDA registered and ISO 13485:2003 certified. Web: www.gauthierbiomedical.com |
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Helix Medical Helix Medical, LLC is a developer, manufacturer and supplier of custom fabricated silicone components and products for the medical device industry world-wide. Our manufacturing capabilities include compression and transfer molding, state-of-the-art Liquid Injection Molding, extrusions, packaging, and assembly. Our platinum-cured silicone products are manufactured following Good Manufacturing Practices (GMP’s) in an FDA registered medical device facility that is certified to meet ISO 13485 Quality Standards. Helix Medical products meet USP Class VI biocompatibility requirements. Web: www.helixmedical.com |
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Hi-Tech Group Consisting of HI-TECH RUBBER, A. C. HOFFMAN, INLAND TECHNOLOGIES, VENTREX, INFINITY and ACCUSIL, the HI-TECH GROUP is a single source contract manufacturer for molded plastic, silicone-rubber components, medical grade tubing and fabricated medical devices. The company offers in-house tooling, rapid prototyping and full scale production in ISO 13485 facilities with Class 10,000 and 100,000 clean-rooms. Web: www.hi-tech-group.com |
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Integrated BioSciences, Inc. Products and equipment available are Class I and II medical devices and disposables and automated equipment. Complete contract manufacturing services for Class I and II medical devices are offered. Capability to design, fabricate and operate automated equipment used in the production of those devices. Web: www.ibiosci.com |
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Invetech Pty. Ltd. Invetech specializes in contract design, development and manufacture of instruments, disposables and automated systems for clinical diagnostics, life sciences, drug discovery and pharmaceutical companies. Our track record includes 60+ projects, with more than 6,000 instruments manufactured. Our in-house team of 150+ engineers, designers and scientists delivers high quality, fast-to-market results at competitive cost. Web: www.invetech.us |
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Jamak Fabrication WEATHERFORD, TX – JAMAK HEALTHCARE TECHNOLOGIES division of Jamak Fabrication is a JMK International Company – manufactures custom silicone extruded and molded components for use in disposable medical devices. JAMAK HEALTHCARE TECHNOLOGIES has over 30-years experience in silicone technology and is a member of the Dow Corning Medical Fabricator’s Network. The company is ISO 9001/QS9000 certified and has a Class 100,000 clean room. Web: www.jamakhealthcare.com |
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LaVezzi Precision Inc. LaVezzi Precision enhances the flexibility of today's machine tools even more with creative programmers and operators. They utilize the latest in multi-tasking equipment along with the auxiliary support required to meet the most demanding production specifications for accuracy, repeatability and rigidity. From micromachining to deburring, our equipment offers you virtually any precision machining operation for nearly every type of geometric specification and tight tolerance you require. Web: www.lavezzi.com |
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Lyons Are you in the early stages of designing a new device? Lyons provides engineering assistance as well as one of the fastest Rapid Prototyping services in the country. Our engineering group will work with you to provide cost effective solutions for your most critical applications including Precision Metal Stampings, Custom Tubing Components, CNC Machined Components, Complete Medical Devices, Assemblies and Sub-Assemblies and Medical Knives and Scissors. Utilizing SolidWorks, Pro/Engineer and AutoCAD Lyons can effectively communicate with your design engineers. Contact Will Lyons at 800-422-9363 Web: www.lyons.com |
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MDeviceNow.com MDeviceNow.com; an exciting new website from the publishers of Medical Product Outsourcing and Orthopedic Design & Technology magazines that is devoted to meeting the information needs of the rapidly growing medical device manufacturing industry. Informative, straightforward and a must-use website for medical device industry professionals, MDeviceNow.com provides invaluable information for medical device product and service releases and buyer’s guide information. Web: www.mdevicenow.com |
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Medical Extrusion Technology Close tolerance extrusions: single and multi-lumen geometrics, profiles, shrink tubings, wire coatings and over-extrusions. Capabilities include bump tubing, vacuum sizing and multi-layer tubing; cut length repeatability to +/- .010”, Irradiation consultation for balloon tubings. Process capabilities for most thermoplastics including polyethylenes, polyurethanes, nylon, PVC, Pebax, CAB, FEP, etc. Prototype and production runs 0.003” to 0.100” diameters. Web: www.medicalextrusion.com |
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Medtech Group, Inc. The MedTech Group is a leading global contract medical device manufacturer. As an ISO Certified 13485:2003 and FDA Registered Medical Device Manufacturer, The MedTech Group provides its customers with design through complete manufacturing services including, product design and development, tooling design and fabrication, process design and validation, surgical staple manufacturing, cleanroom molding including two-shot and insert molding, complete device assembly and packaging, sterility validation and management. Our website offers a password protected project center which gives our customers the opportunity for 24/7 access to updates on their project, instant meetings online and real time web meetings. Web: www.medtech-grp.com |
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Metal Cutting Corp. This company can cut to length the most difficult metal tubing used in the medical device business. The burr-free parts have no deformation or contamination. Any type of metal can be cut, with lengths as short as 0.25 mm with wall thicknesses as thin as 0.025 mm or inside diameters as small as 0.025 mm. Web: www.metalcutting.com |
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MicroLumen Inc. MicroLumen, Inc. manufactures HIGH PERFORMANCE MEDICAL TUBING and Sub-assembly. Ideal for catheter shafts and low-invasive medical devices; Cardiovascular, Neurological, Urological applications. Braid & Coil reinforced designs available for added torque and column strength. PTFE liners, flexible tips, embedded marker bands, multi-durometer constructions and custom laser-machining available. ID range: 0.10mm to 2.11mm with superior mechanical properties. Web: www.microlumen.com |
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Modified Polymer Components Development resources: drafting, design, material selection, prototyping, in house machine shop, custom equipment fabrication, pilot production builds. Manufacturing resources: intricate manual assembly, bonding, tipping, laminating, forming, soldering and more. M.P.C. offers over 8000 sq. ft. of controlled environment for general manufacturing, 2000+ sq. ft. for development projects, flow hoods for clean applications, and a portable clean room. ISO 9001 and 13485 certified. Web: www.modifiedpolymer.com |
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MRPC MRPC is a single-source provider of innovative medical device components and assemblies. The company offers design engineering assistance and custom material development. Manufacturing capabilities include silicone molding, TPE molding, custom rubber molding, silicone extrusions, two-material molding, and laser machining. MRPC is ISO 9001:2000 certified with Class 100,000 and Class 10,000 clean room processing. Web: www.mrpcorp.com |
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National Cable Molding National Cable Molding is an ISO 9001 certified and FDA registered manufacturer specializing in molded cable assemblies for electro-medical equipment. We deliver 30+ years of material selection knowledge and technical manufacturing experience to meet the critical care needs of our clients. Web: www.nationalwire.com |
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NDH Medical, Inc. NDH Medical, Inc. is a contract manufacturer of single use medical devices. Specializing in custom extrusion, NDH provides single and multi-lumen tubing, co-extrusions, tapered tubing, and paratubing available in a wide range of medical grade thermoplastics. Wire and coil coating (continuous and discrete lengths), injection molding, insert molding, tip forming, hole punching, printing, and packaging services are also available, as is turnkey manufacturing and inventory management. In-house tooling design and fabrication is available to reduce project lead times. Volumes from research and development runs to large scale ongoing production runs can be easily accommodated. Web: www.ndhmedical.com |
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New England Wire New England Wire Technologies provides solutions through the design, development, testing and manufacture of specialty wire products that meet exacting specifications for applications in medical, automotive, communications, computer, industrial electronics, robotics, and high-energy physics industries. Our subsidiary New England Catheter develops designs and manufactures braid-reinforced tubing for medical device industry. Web: www.newenglandwire.com |
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Nitinol Devices & Components Fully integrated producer of Nitinol shape memory and superelastic materials and custom Nitinol components in ISO 13485:2003 certified facilities. We manufacture Nitinol wire, tube, strip and sheet materials; and provide Nitinol cutting, forming, laser machining, surface finishing, electro-polishing, prototyping and full scale production facilities. We also offer testing services (mechanical properties, corrosion, FEM, failure analysis, fatigue). Web: www.nitinol.com |
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Norman Noble Norman Noble Inc. has contract manufacturing capabilities that meet the complexity of micromachining and include laser micromachining, laser welding, wire EDM, CNC Swiss machining, and shape setting of Nitinol. Prototype machining services ensure the accuracy of the final product. Laser, Swiss, and Wire EDM R&D departments are located near production, at one location. The company is registered to 9001:2000 and ISO 13485:2003. Web: www.nnoble.com |
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Omnica Corp. Omnica Corporation offers comprehensive medical product design and engineering; research and development services; design control compliance and regulatory doc-umentation; realistic CAD rendering and animations; fully equipped CNC prototyping and modelmaking shops. All aspects of medical product development from concept through hand-off to production. Twenty-seven full-time employees perform all principle services in-house. Web: www.omnica.com |
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Peridot Corp. Peridot Corporation, manufacturer of precision parts and surgical components has announced that, in addition to its current ISO 9001:2000 registration, the company is proud to have achieved ISO 13485:2003 Certification. More about the new Peridot Clean Room Division and its recent ISO 13485:2003 Certification be found on the Peridot web site, www.peridotcorp.com, or by calling Mr. Pickerell at 925-461-8830. Web: www.peridot.com |
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Phillips & Johnston, Inc. Phillips & Johnston, Inc. has specialized in quality tubular products for more than forty years. The company offers very tight tolerances (+/- .0001”) and a range of services including ultra smooth ID capability, upon request. Quick turnaround of orders and precision fabrication such as cutting, slotting, bending, beveling and EDM are also available. Web: www.pjtube.com |
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Phillips Plastics Skilled at designing for multiple molding processes, Phillips' designers bring the manufacturing per-spective to the concept phase. Add to that four FDA registered facilities with over 100,000 square feet dedicated to medical manufacturing and you have a total solutions partner. Web: www.phillipsmedicalmolding.com |
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Pilgrim Software Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management software solutions for global organizations in the medical products industry. Pilgrim's fully Web-based solutions help medical products organizations ensure product safety and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. Web: www.pilgrimsoftware.com |
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Potomac Photonics, Inc. Potomac Photonics (experts in miniaturization) provides contract-manufacturing services from prototype to production. A wide variety of materials can be processed, such as polymers, metals, ceramics and glass. Feature sizes less than two microns can be realized in most materials. Potomac Photonics is ISO 9001:2000 certified and can process prototypes within 48 hours. Web: www.potomac-laser.com |
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PPC While specializing in development projects, Putnam also offers a state-of-the-art manufacturing facility which naturally, has achieved ISO 9002 certification and reaffirms the company's goal of maintaining a quality system of the highest possible standards. Along with a full line of products, Putnam provides the latest in online statistical quality control. Further, a Class 100,000 cleanroom is ideal for implantable and thin-wall medical tubing. Web: www.putnamplastics.com |
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PPC Plus Our dedicated focus to providing Secondary Operation Solutions within Putnam Plastics Company, offers customers the added benefits of efficiency, traceability and consolidated resources. Eliminate the variables stopping you from getting your device to market faster. Choose a manufacturing partner who understands the value of a streamlined supply chain. Web: www.putnamplus.com |
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Precision Extrusion Inc. Precision Extrusion is an ISO 9001:2000 certified custom manufacturer of close-tolerance single and multi-lumen small-diameter tubing including coextruded and reinforced (braided) configurations, and solid acetal mandrel (with silicone release) in the medical industry. ID’s as small as 0.0025” and walls as thin as 0.002” are possible. Materials include PVC, PUR, PA, PC, PEEK, FEP, LCP, PE, acetal and other most engineering resins from commercial to medical grade. Web: www.precisionextrusion.com |
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Scantibodies Laboratory SCANTIBODIES showcases its new Contract Manufacturing Facility in Tecate, Mexico, in their OEM book The Advantages of Outsourcing with Scantibodies Laboratory, Inc. The book shows the new 125,000 sq. ft. facility, with a pictorial display of current award-winning OEM operations being performed in Tecate. The facility celebrated a grand opening in May, 2007. Web: www.scantibodies.com |
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Specialized Medical Devices Implants – Instruments – Class 10,000 Clean Room Packaging. SMD specializes in complete spinal implant systems, small bone implant systems as well as custom orthopedic instrumentation. SMD is a full service manufacturer from prototype runs to full production. SMD’s expansive in-house capabilities include: Ultra precise CNC-Swiss screw machining, 5-axis vertical milling, wire EDM, titanium anodization, a validated implant cleaning process, heat treating, laser marking, anodizing, electropolishing and passivation. Materials: titanium, stainless steel, cobalt chrome and Peek. FDA registered, ISO 13485:2003 certified. Web: www.specializedmedical.com |
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STERIS Isomedix Services STERIS Isomedix Services is pleased to announce the launch of its new website, www.isomedix.com. This site has an entirely new look, updated content and improved navigation, providing visitors with easy access to information on contract sterilization, processing technologies, validation, and other services provided by the company. Web: www.isomedix.com |
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SYMMETRY Medical Inc. Symmetry Medical is a leading independent provider of implants and related instruments and cases to the orthopedic device industry. The company also designs, develops and produces these products for companies in other segments of the medical device market, including arthroscopy, dental, laparoscopy, osteobiologic and endoscopy sectors, and provides limited specialized products and services to non-healthcare markets. Web: www.symmetrymedical.com |
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Syncro Corporation Syncro Corporation has been providing product development and manufacturing support to contract manufacturing customers requiring electronic and/or electromechanical subsystems and products for over half a century. Our combination of vertical integration and depth of expertise in supporting complete product life cycles from development through depot repair enables us to closely align our project support with whatever mix of capabilities our customers require. Web: www.syncroems.com |
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Tech Group With over 40 years of experience, the Tech Group specializes in custom molding and contract manufacturing solutions for the medical device and pharmaceutical industries worldwide. Projects range from product design and development, tool design and fabrication, process design, validation, production and final packaging. The Tech Group is a Class II and Class III medical device manufacturer and operates 13 facilities throughout the United States, Mexico and Europe. Web: www.techgroup.com |
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Tech-Etch, Inc. PHOTOETCHING LIGHT-GAUGE MEDICAL PARTS FROM BIOMATERIALS Brochure describes how the photoetching process produces intricate parts for diverse medical applications. Contains photographs of over 100 parts. Applications include screens, masks, filters, lead frames, flat springs, strain gauges, laminations, implants, blades, and stents. Biomaterials titanium, tungsten, nitinol, molybdenum, elgiloy, and polyimide can be etched. In-house forming, laminating, heat treatment, assembly and finishing are available. Web: www.tech-etch.com |
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Teel Plastics Teel Plastics manufactures quality, close tolerance custom tubing from .015" OD and up for the Healthcare Market. Applications include catheters, catheter packaging, IV sets, ampoules, and swabs. We have coextrusion capabilities, a Class 100,000 Cleanroom, and are ISO 9001 certified. New 150,000 square foot state of the art extrusion facility. Web: www.teel.com |
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Zeus, Inc. Years of experience have made Zeus the industry pioneer of multi-lumen tubing. We can custom manufacture high-quality multi-lumen tubing with numerous custom passages and tight tolerances using a number of different resins. Zeus specializes in high performance polymer extrusions. Resins include PTFE, FEP, PFA, PEEK, PEEKshrink(tm), and Pebax. In-house research team develops custom solutions. Products include extruded, heat-shrink, Sub-Lite-Wall(r), ePTFE, multi-lumen, and Lay-Flat tubing. Web: www.zeusinc.com |
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