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Advanced Scientifics Advanced Scientifics Inc. is a fully integrated, FDA registered, ISO 13485:2003 certified contract manufacturer of class I and II Disposable Medical Devices, specializing in fluid management. From product design/prototyping to finished sterile packaging, ASI is your complete resource for contract manufacturing of high quality, medical disposables. Web: www.advancedscientifics.com |
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Amphenol Medical Solutions Amphenol Medical Solutions provides a comprehensive array of connectivity -- from critical components to complete solutions as well as performance-engineered cable assemblies. AMS offers the latest technology including: high density, high speed, high voltage, high current, EMI shielding, filtering, flex circuitry and hybrid connections that can combine fiber, copper, fluids, and gases in a complete package. Web: www.amphenolmedical.com |
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Applied Manufacturing Technologies Inc. Your most reliable partner in Contract Manufacturing Services for: • Catheters & Medical Devices Printing • Laser Marking, Engraving, Drilling and Cutting • Pad Printing • Hot Stamp & Heat Transfer • Corona & Plasma Treating • Ultrasonic Welding & Assembly Web: www.amtecinc.com |
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B Braun OEM Division, B. Braun Medical, Inc. The B. Braun OEM Division delivers complete contract manufacturing capabilities, focusing on Class II and Class III medical devices. The company manufactures thousands of standard and specialty items from components to custom trays. Services available include research and development, design, prototyping, tooling, molding, validation, manufacturing, packaging, sterilization, quality control, private labeling and regulatory guidance. Web: www.bbraunoem.com |
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benlan Inc. Benlan offers a wide range of “medical focused” contract manufacturing services including; • Component parts – extruded, injection molded and assembled • Medical Devices – finished assemblies both bulk non-sterile and packaged sterile • Kit packing, bagging, and various form-fill-and-seal operations • Private label and special packaging options with high resolution printing capabilities • Engineering and design services as well as support in regulatory compliance and sterilization validations Web: www.benlan.com |
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Covidien The Covidien OEM and Custom Product Solutions Division is dedicated to delivering high quality medical and custom engineering products to the Medical Device, Pharmaceutical, Consumer, Rehabilitation, and Industrial Markets. Drawing from the diverse manufacturing capabilities of 67 manufacturing facilities worldwide, Covidien OEM offers our customers and partners a single source for custom product design and development, and of the broadest standard product offerings in the medical device industry today. Web: www.covidien.com |
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Crescent Industries ISO 13485:2003 & ISO 9001:2008 registered, Crescent Industries is a single source provider for custom injection molded plastic components using high performance thermoplastics in a variety of molding services. Crescent offers product design & development, new mold builds class 101-105, and contract manufacturing services. Our medical molding division, Crescent Medical Plastics is dedicated to manufacturing medical devices. Web: www.crescentind.com |
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D&R Products D&R Products is an FDA registered medical device contract manufacturer specializing in cutting edges on a wide variety of standard and exotic metals. In-house services include: CNC grinding, turning/milling, plasma/laser welding, wire EDM, electropolishing, assembly and packaging. Capabilities include holding =/- 0.0001" tolerance, delivering fiscally responsible, quality products, on time. Web: www.drproducts.com |
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DDL, Inc. DDL is a full service testing lab specializing in medical device package, product and material testing. DDL has the experience and the knowledge to guide you to the right standard and help you better understand your testing requirements and your results. Considered a national leader and innovator in the testing industry since 1990, our certified packaging engineers and three full-service testing laboratories will provide the expertise to validate the efficacy of your packaging systems. Web: www.testedandproven.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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EtQ Solutions EtQ's Solution for Life Sciences is an integrated quality management and FDA compliance software system that has been pre-configured to specifically address the needs of the Life Sciences industry, and exceed cGxP/GMP standards and 21 CFR Part 11 compliance requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. These modules are tightly integrated to deliver a best-in-class FDA Compliance Software solution. Web: www.etq.com/gxp/ |
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Helix Medical Founded in 1984, Helix Medical is a custom manufacturer for the medical device industry worldwide. Capabilities include silicone and thermoplastic molding and extrusion, assembly, and packaging. Helix Medical operates an FDA-registered medical device facility, certified ISO 13485 with Class 7&8 cleanrooms. Medical manufacturing operations located in California, Massachusetts, Europe, Asia. Web: www.helixmedical.com |
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Holmed Corporation Holmed is a one-stop source for O.E.M. products and our own designed instruments. Our main focus is on “MIS” products, cutting devices, molded handle products, torque instruments, retractor systems, and general use products. Web: www.holmed.net |
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Hypertronics Hypertronics expertise is in precision design and manufacturing of electronic interconnect systems. We provide complete solutions for any application that requires the highest level of reliability. Whether it’s custom or standard, we have a full offering of connectors, cable assemblies, mechanical or instrumentation housing, electrical modeling and testing. Web: www.hypertronics.com |
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Interface Catheter Solutions Interface Catheter Solutions is the only vertically integrated provider of outsourced solutions for balloon catheter manufacturing. Interface provides extruded balloon tubing, design and development, custom and standard balloons, and balloon contract manufacturing. Interface also provides balloon forming, catheter production, and testing equipment. Interface is ISO 13485:2003 certified and operates multiple class 10,000 and 100,000 clean rooms. Web: www.interfaceusa.com |
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Inzign Pte. Ltd. Inzign is a niche contract manufacturer specializing in plastics injection molding and assembly of disposable devices for its customers in the biomedical industry. Inzign is staffed with a team of professionals with proven knowledge and track records in process validation per FDA cGMP compliant 21 CFR Part 820. Inzign's four manufacturing facilities include Class 10,000 and 100,000 cleanrooms located in Singapore and Indonesia that are ISO 9001:2000 and ISO 13485:2003 certified. Web: www.inzign.com |
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Kent Elastomers The Kent Elastomer Products, Inc., website features in-depth product information, data sheets and literature, and a user-friendly image gallery. Easy navigation makes it simple for visitors to find the right product, data sheet or literature for their application. Web: www.kentelastomer.com |
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Lyons Supplying RAPID Prototyping and production services to the medical device, instrumentation and implants industries. Proprietary tooling and processes and a “can do” approach have given Lyons a reputation as a leading provider of complete devices, welded and mechanical assemblies, CNC machined components, metal stampings, tubing and surgical scissors and sharps. Lyons, Medical Device Solutions, Meriden, CT. Web: www.lyons.com |
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MasterBond Adhesives/Sealants/Coatings Easy to navigate, informative web site describes Master Bond adhesive, sealant, coating, potting and encapsulation formulations. Line consists of epoxies, silicones, polyurethanes, cyanoacrylates and UV cures. Specific grades are available which are USP Class VI certified and resistant to repeated cycles of sterilization. We provide prompt technical assistance and solve problems. Web: www.masterbond.com |
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Medefab Medafab is a single-source, full-service, FDA-registered, ISO-certified medical product manufacturer. Complete in-house capabilities include tubing extrusion, insert and loose-piece molding, assembly, printing & decorating, hot stamp marking & other finishing operations. Disposable components and products are manufactured to the highest quality standard following strict production guidelines in order to meet the stringent demands of a broad range of medical specialties. Web: www.medefab.com |
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Millstone Medical Outsourcing Millstone Medical Outsourcing is a leading and innovative provider of customized outsourcing solutions to the medical device industry. We offer advanced mechanical inspection, sterile and non-sterile packaging, loaner kit processing, and distribution services to manufacturers worldwide. Web: www.millstonemedical.com |
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Minnesota Rubber & Plastics Minnesota Rubber and Plastics is a custom medical molder of rubber and plastic components including assemblies. Specializing in high performance materials we offer a complete solutions approach with services including product development, tool design and fabrication, prototyping, insert molding, silicone over-molding, assembly, class 10,000 and 100,000 clean rooms / packaging.Global manufacturing in 9 facilities. ISO 13485 certified and FDA registered. FDA Class 1,2, and 3 products including CE Products. Web: www.mnrubber.com |
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Modified Polymer Components Your partner for component level engineering and manufacturing. Providing innovative solutions to difficult challenges in order to deliver the best-quality, stable manufacturing services. Experienced with PEBAX, PE, Ultem, PEEK, FEP, PFA, PTFE and any thermoplastic. Tipping, flaring, hole drilling, marker band placement, printing, electrode assembly, and component level assemblies. 20 years serving the Medical Device and Diagnostic industries. ISO 9001/13485 Certified. Web: www.modifiedpolymer.com |
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NDC - Nitinol Devices & Components, Inc. From material supply to component fabrication, and device design to testing, analysis, simulation, and regulatory support, NDC is the world's most complete provider of Nitinol material and services. Stay updated with Nitinol developments at NitinolUniversity.com and on Twitter @WeAreNitinol. Web: www.nitinol.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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OraTech OraTech offers vertical integration specializing in manufacturing and packaging that meets precise specifications in the Medical industry. OraTech offers multiple services including Injection Molding, Thermoforming, Packout/Fullfilment, Blow Fill and Seal, Formulation/Batching, Tube Filling, Medical Machining, OraTech’s turnkey programs combine your companies industry knowledge with our manufacturing expertise to significantly reduce the time-to-market and improve profitability. Web: www.Oratech.com |
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Peridot Corporation Peridot is an ISO 9001:2000 and ISO 13485:2003-certified precision component manufacturer offering complete design, prototyping and fabrication services. Our engineers and technicians have extensive expertise with an exceptionally wide range of machine and laser fabrication processes for the custom creation of virtually any precision component imaginable. And we love a good challenge! Find out more today at Peridotcorp.com. Web: www.peridotcorp.com |
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Phillips Plastics Skilled at designing for multiple molding processes, Phillips' designers bring the manufacturing perspective to the concept phase. Add to that 176,000 square feet of FDA registered facilities dedicated to high volume and clean room medical manufacturing including a pilot facility to support clinical builds and you have a total solutions partner. Web: www.phillipsmedicalmolding.com |
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Potomac Photonics 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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Proven Process Proven Process Medical Devices is an ISO 13485: 2003 certified and FDA registered full-service outsourcing partner that offers exceptional design, development, validation and contract manufacturing services exclusively for the medical device industry. Proven Process provides expertise in mechanical engineering, digital and analog electrical engineering, software engineering, and contract manufacturing to established and emerging companies marketing novel Class II and Class III therapeutic and diagnostic medical products. Web: www.provenprocess.com |
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PTI Engineered Plastics PTI Engineered Plastics is ISO 13485 certified and is a leading innovator in plastic injection molding. For over twenty-five years, PTI has provided the medical community with low and high volume production with a specialty in complex injection molded products. In our state-of-the-art 100K cleanroom, we have the ability to perform injection molding, assembly, secondary operations, and packaging. Also, available to our customers’ are the full resources of our in-house design studio. Some of the other value-added services include part decorating, product assembly, insert molding and soft touch overmolding. Web: www.teampti.com |
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Saint-Gobain Performance Plastics An expert in development of high-performance polymer products, Saint-Gobain offers standard and custom extrusion and molding in silicone, thermoplastic elastomers, and fluoropolymers. Saint-Gobain’s molding capabilities include transfer, two-shot, micro, and insert molding. The company also offers design engineering, R&D, rapid prototyping, and assembly. With 13 global manufacturing sites, Saint-Gobain is your global partner in manufacturing. Web: www.medical.saint-gobain.com |
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SMC Ltd. SMC Ltd. offers OEM’s product manufacturing services including design, prototyping, molded components, subassemblies, and finished devices. With a global presence in North America and Asia, SMC’s facilities offer ISO 13485 certified quality systems with Class 7, Class 8, and white room molding and assembly environments. Web: www.smcltd.com |
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TechDevice Corporation TechDevice Corporation, a developer, manufacturer and assembler of a select focus of interrelated products, welcomes OEMs to its recently updated Web site, www.techdevice.com. New content features include comprehensive specifications on the full-line of TDXPress ready-access products and TechDevice’s expanding precision grinding capabilities. Also, exciting new developments to TechDevice’s core product lines and manufacturing services are showcased on this content rich Web site. Web: www.techdevice.com |
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Tegra Medical Tegra Medical is a leading supplier of centerless grinding, laser processing, Swiss-style turning, CNC milling/turning, EDM, electrochemical machining, insert molding and assembly with 180,000 sq. ft. of modern manufacturing space in Boston and Memphis (25,000 sq. ft. for prototyping). We offer real-time SPC and paperless quality system registered to ISO 13485. Web: www.tegramedical.com |
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Value Plastics, Inc. For over 40 years Value Plastics has designed and manufactured plastic tubing fittings and connectors from Fort Collins, Colorado. Products available from stock include over 3,400 different style and material combinations. Web: www.valueplastics.com |
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Vesta Vesta is a global manufacturing and support services company for the OEM medical device industry, providing silicone moldings, precision silicone and thermoplastic extruded tubing, assemblies and secondary operations within ISO-certified facilities. Leveraging expertise in quality standards, product design, and material selection, Vesta infuses value throughout the product life cycle. Web: www.vestainc.com |
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Ximedica, LLC Ximedica provides comprehensive product development and advanced manufacturing services to the world’s leading medical device and consumer healthcare companies. Our expertise includes research, human factors industrial design, mechanical and electrical engineering, clinical & regulatory and advanced manufacturing and assembly. We are results-driven and committed to quality and your success. Web: www.ximedica.com |
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