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Selected Supplier Qualifications

ISO 13485 is a family term that refers to a standard developed and published by the International Organization for Standardization (ISO). ISO 13485 certifications are for organizations that provide medical devices.

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SIMTEC Silicone Parts, LLC - Miramar, FL Browse our capabilities profile
Custom Manufacturer
Custom manufacturer of molded plastics. Capabilities include fabrication, designing, prototyping and injection, liquid injection and over molding. Medical, consumer, automotive, kitchenware and home entertainment industries served. On-time delivery.
Quadrant Engineering Plastic Products, Inc. - Reading, PA
Manufacturer, Custom Manufacturer, Service Company
Manufacturer of molded plastic shapes for machining. Produced in rod, sheet, tubular bar & custom shapes. Plastics produced include Acetron®, Nylatron®, MC, Ertalyte®, Fluorosint®, Techtron®, Torlon® & Semitron® ESD.
Globe Medical Tech, Inc. - Houston, TX Browse our catalog of products
Custom Manufacturer, Service Company
Plastic injection molding services specializing in safety medical devices and drug delivery systems. Capable of providing test and sample molds. Capabilities include mold tool making, multi-cavity production molding, blow molding, co-injection molding, composite molding, compression molding and flashless rubber molding. Other services include of product design and development, cleanroom injection mold making, consulting, manufacturing and turnkey solutions.
Molded Devices, Inc - Riverside, CA Browse our catalog of products
Manufacturer, Custom Manufacturer
Injection and dip-molded plastic fabrication services. Available in vinyl, plastisol, or PVC in various colors and finishes. Standard and custom caps, containers, pouches, sleeves, busbar boots, corner protectors and medical balloons are also available. Other capabilities include injection molding, dip coating and powder coating. Services available are rapid prototyping, tool manufacturing, printing, assembly and packaging.
Tomken Plastic Technologies, Inc. - Muncie, IN
Manufacturer, Custom Manufacturer, Service Company
Woman-owned. ISO 9001:2008 & TS/ISO 16949:2009 certified. Custom manufacturer of machined and molded plastics. Various plastic products include bases, bearings, bins, bobbins, bolts, bowls, boxes, bumpers, bushings, cups, fans, fasteners, fittings, fixtures, grommets, handles, hinges, hooks, housings, knobs, latches, levers, locks, louvers, pins, plugs, sleeves, spacers, spools, ties, washers and wheels. Various materials include ABS, acetal, acrylic, AES, alkyd, fluoroelastomer, fluoropolymer, HDPE, MABS, nylon, PCT, PE, PF, PFA, phenolic, PLA, PMP, polyarylate, polyester, siloxane, TS and TSU. Capabilities include tooling, engineering, assembly, inspection, designing, molding, ultrasonic welding, heat staking, pad printing, repair and pressing. Various applications include automotive, medical, electronic and commercial. ISO 13485 and AS 9100 compliant. On-time delivery.
Marman Industries - La Verne, CA
Custom Manufacturer
Custom manufacturer of molded plastics. Injection molding, insert molding & over molding services are available. Capabilities include class 100,000 cleanroom molding, contract manufacturing, prototyping, mold designing, mold building, mold repair, modification & maintenance, mold testing & first article inspection. Value added services include product end-item assembly, product sub-assembly, primary & secondary packaging, sterilization prepping & configuration, silk screening, pad printing & laser marking.
Sarasota Precision Engineering - Sarasota, FL
Custom Manufacturer, Service Company
Custom manufacturer of molded plastics. Materials such as thermoplastic resins and high performance engineering resins are used. Plastic parts for automotive, medical and aerospace applications can be molded. Capabilities include engineering, product development, tooling, injection molding, insert molding and over molding.
Tessy Plastics Corp. - Elbridge, NY
Manufacturer, Custom Manufacturer
Manufacturer of gears, custom injection molded plastic parts & assemblies.
Hy-Ten Plastics - Milford, NH
Manufacturer, Custom Manufacturer, Service Company
Manufacturer of custom injection molders & moldmakers. Specializing in high tolerance, high temperature engineering resins. Full product design & product development services. Injection molding 22-275 ton. Clean & white room molding. ISO 9001 certified.
Acro-Matic Plastics - Leominster, MA
Manufacturer, Custom Manufacturer, Service Company
Industrial, Electronics, Medical, & Automotive
Group Dekko Inc. - Garrett, IN
Custom Manufacturer, Service Company
Contract custom manufacturer of cleanroom molded or assembled plastics. Appliance parts, lighting parts, medical device parts, office furniture electrical parts, electrical products, molded wire harnesses & sensors for automotives are fabricated. Shot sizes range from 2 oz. to 16 lbs. Capabilities include design, prototyping, insert molding, injection molding & over molding. Products are tested as per A2LA standards & are UL® listed.
Parkway Products - Florence, KY
Manufacturer, Custom Manufacturer, Service Company
ISO 9001:2000, ISO 14001:2004, TS 16949, ISO 13485 & UL certified custom fabricator of insert molded plastics. Materials also include polyester, vinyl ester, epoxy, bismaleimide, polyurethane, phenolic, silicone, urea formaldehyde, urea melamine, PEEK®, Stanyl®, Delrin®, Xenoy®, acrylonitrile butadiene styrene (ABS), polypropylene (PP), polyethylene (PE), polystyrene (PS), polymers, thermosets, Torlon®, Ultem®, Amodel®, Udel®, Aurum® & Fortron®. Capabilities include assembly, tool designing, engineering, finishing, curing, CNC machining, deflashing, laser marking, painting, pad printing, ultrasonic welding, parts kitting & hot stamping.
PEDI - Plastics Engineering & Development, Inc. - Vista, CA
Manufacturer, Custom Manufacturer
ISO 9001:2000 certified manufacturer of molded plastics including short run molded plastics & overmolded plastics. Applications include biomedical assemblies & medical device manufacturing. Capabilities include sonic welding, heat sealing, in-process packaging, & final packaging. Features include Class 100,000 cleanroom capacity. Additional products include injection molded medical & biomedical plastics, closures, medical devices, irrigation parts, knee braces, & electrical connectors.Industries served include electronics, consumer, industrial, & recreational. ISO 13845: 2003 & FDA certified & UL recognized.
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