Surgical Retractor Suppliers
Limit companies to: Worldwide USA
American Distributors Of Colon And Rectal Supplies | Address: 1 Spring Knoll Court, Lutherville, Maryland 21093, USA 
www.adcrs.com | Send Inquiry | Phone: +1-(877)-207-2826
Products: Anoscopes, Dilators, Anal Retractor, Proctoscopes (FDA Code: GCF), Fiberoptic Cables, Surgical Retractor (FDA Code: GAD), ...
American Distributors Of Colon And Rectal Supplies provides solution and systems for colon proctology and rectal surgery. Our products include Dilatan ®, disposable devices, surgical tools and ele more...
www.adcrs.com | Send Inquiry | Phone: +1-(877)-207-2826
Products: Anoscopes, Dilators, Anal Retractor, Proctoscopes (FDA Code: GCF), Fiberoptic Cables, Surgical Retractor (FDA Code: GAD), ...
American Distributors Of Colon And Rectal Supplies provides solution and systems for colon proctology and rectal surgery. Our products include Dilatan ®, disposable devices, surgical tools and ele more...
Lemaitre Vascular, Inc. | Address: 63 Second Avenue, Burlington, Massachusetts 01803, USA
www.lemaitre.com | Send Inquiry | Phone: +1-(781)-221-2266
FDA Registration: 1220948 Year Established: 1983 Annual Revenues: USD 25-50 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Mesh (FDA Code: FTM), Embolectomy Catheters (FDA Code: DXE), Adhesive Bandages (FDA Code: KGX), Temporary Microvascular Clips, Neurosurgery, Surgical Retractor Systems (FDA Code: GAD), ...
LeMaitre Vascular, Inc. is a global provider of devices for the treatment of peripheral vascular disease. We develop, manufacture, and market disposable & implantable vascular devices to address the n more...
www.lemaitre.com | Send Inquiry | Phone: +1-(781)-221-2266
FDA Registration: 1220948 Year Established: 1983 Annual Revenues: USD 25-50 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Mesh (FDA Code: FTM), Embolectomy Catheters (FDA Code: DXE), Adhesive Bandages (FDA Code: KGX), Temporary Microvascular Clips, Neurosurgery, Surgical Retractor Systems (FDA Code: GAD), ...
LeMaitre Vascular, Inc. is a global provider of devices for the treatment of peripheral vascular disease. We develop, manufacture, and market disposable & implantable vascular devices to address the n more...
Rocket Medical | Address: 150 Recreation Park Drive, Unit 3, Hingham, Massachusetts 02043, USA
www.rocketmedical.com | Send Inquiry | Phone: +1-(781)-749-6223, 800-707-7625
FDA Registration: 3004056053 Year Established: 1964 Annual Revenues: USD 10-25 Million Quality: ISO 9001, ISO 13485, CE Certified
Products: Biopsy Forceps, Drainage Catheter, Surgical Retractor Systems (FDA Code: GAD), Aspiration Needles, Bone Marrow Biopsy Needle, Amniotome (FDA Code: HGE), ...
Rocket Medical deals with products for cardiac and thoracic drainage, ascites drainage, infertility, labor ward, colposcopy, and sterile supplies. Our Rocket® Genesis™ embryo transfer cathet more...
www.rocketmedical.com | Send Inquiry | Phone: +1-(781)-749-6223, 800-707-7625
FDA Registration: 3004056053 Year Established: 1964 Annual Revenues: USD 10-25 Million Quality: ISO 9001, ISO 13485, CE Certified
Products: Biopsy Forceps, Drainage Catheter, Surgical Retractor Systems (FDA Code: GAD), Aspiration Needles, Bone Marrow Biopsy Needle, Amniotome (FDA Code: HGE), ...
Rocket Medical deals with products for cardiac and thoracic drainage, ascites drainage, infertility, labor ward, colposcopy, and sterile supplies. Our Rocket® Genesis™ embryo transfer cathet more...
Duro Surgical | Address: 45 Landon Road, Milton, Massachusetts 02186, USA
www.durosurgical.com | Phone: +1-(617)-759-7612
Products: Nitrile Gloves, Disposable Gloves, Disposable Examination Nitrile Gloves, Latex Gloves, Washer Disinfectors, Latex Free Nitrile Gloves, ...
Duro Surgical provides support and guidance in the area of SPD designs, workflows, processing, decontamination, sterilization practices and instrument turnovers. We develop surgical retractor and surg more...
www.durosurgical.com | Phone: +1-(617)-759-7612
Products: Nitrile Gloves, Disposable Gloves, Disposable Examination Nitrile Gloves, Latex Gloves, Washer Disinfectors, Latex Free Nitrile Gloves, ...
Duro Surgical provides support and guidance in the area of SPD designs, workflows, processing, decontamination, sterilization practices and instrument turnovers. We develop surgical retractor and surg more...
Intact Medical Corporation | Address: One Apple Hill Suite 316, Natick, Massachusetts 01760, USA
www.intactmedical.com | Send Inquiry | Phone: +1-(508)-6557820, 888-430-4490
Products: Surgical Retractor Systems (FDA Code: GAD), Biopsy Instruments (FDA Code: KNW), Surgical Retractor (FDA Code: GAD), Biopsy Instruments (FDA Code: KNW), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Implantable Staple (FDA Code: GDW), ...
Intact Medical Corporation provides minimally invasive systems for the volumetric excision of tissue for diagnostic and therapeutic applications. Our Intact™ breast lesion excision system (BLES) more...
www.intactmedical.com | Send Inquiry | Phone: +1-(508)-6557820, 888-430-4490
Products: Surgical Retractor Systems (FDA Code: GAD), Biopsy Instruments (FDA Code: KNW), Surgical Retractor (FDA Code: GAD), Biopsy Instruments (FDA Code: KNW), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Implantable Staple (FDA Code: GDW), ...
Intact Medical Corporation provides minimally invasive systems for the volumetric excision of tissue for diagnostic and therapeutic applications. Our Intact™ breast lesion excision system (BLES) more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Tuzik Corporation | Address: 104 Longwater Dr., Norwell, Massachusetts 02061-1610, USA
Send Inquiry | Phone: +1-(781)-878-6363
Annual Revenues: < USD 1 Million
Products: Forceps (FDA Code: HTD), Surgical Microscopes, Surgical Scalpels, Surgical Monitoring, Instruments surgical, Surgical Needles, Reusable, ...
Tuzik Corporation specializes in surgical products. more...
Send Inquiry | Phone: +1-(781)-878-6363
Annual Revenues: < USD 1 Million
Products: Forceps (FDA Code: HTD), Surgical Microscopes, Surgical Scalpels, Surgical Monitoring, Instruments surgical, Surgical Needles, Reusable, ...
Tuzik Corporation specializes in surgical products. more...
Holmed Corporation | Address: 40 Norfolk Avenue, South Easton, Massachusetts 2375, USA
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
Pioneer Surgical Technology | Address: 375 River Park Circle, Marquette, Michigan 49855, USA
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
Signal Medical Corp. | Address: 400 Pyramid Dr., Marysville, Michigan 48040, USA
www.signalmd.com | Phone: +1-(810)-364-7070 800-246-6324
FDA Registration: 1836001
Products: Hip Positioner Systems, Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Cancellous Bone Screw, Hip Products, Osteogators, Bipolar Femoral Heads, ...
Signal Medical Corp. manufactures orthopedic surgical appliances. Our product area includes hip products, knee products, cable systems and instrumentation. The Micro Seal® acetabular component sea more...
www.signalmd.com | Phone: +1-(810)-364-7070 800-246-6324
FDA Registration: 1836001
Products: Hip Positioner Systems, Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Cancellous Bone Screw, Hip Products, Osteogators, Bipolar Femoral Heads, ...
Signal Medical Corp. manufactures orthopedic surgical appliances. Our product area includes hip products, knee products, cable systems and instrumentation. The Micro Seal® acetabular component sea more...
Sterilmed, Inc. | Address: 11400 73rd Ave. North, #100, Maple Grove, Minnesota 55369, USA
www.sterilmed.com | Send Inquiry | Phone: +1-(763)-488-3400, 888-252-1542
FDA Registration: 2134070
Products: Oxygen Masks (FDA Code: BYG), Guidewires, Tunnel Blades, Arthroscopes (FDA Code: HRX), Chisels, Electrode Cables (FDA Code: IKD), ...
Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-own more...
www.sterilmed.com | Send Inquiry | Phone: +1-(763)-488-3400, 888-252-1542
FDA Registration: 2134070
Products: Oxygen Masks (FDA Code: BYG), Guidewires, Tunnel Blades, Arthroscopes (FDA Code: HRX), Chisels, Electrode Cables (FDA Code: IKD), ...
Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-own more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
SIM Surgical | Address: 1650 Headland Drive, St. Louis, Missouri 63026, USA
www.simsurgical.com | Send Inquiry | Phone: +1-(800)-521-2985
FDA Registration: 1935627 Year Established: 2001 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 13485 Certified
Products: Probes (FDA Code: HXB), Common Surgical Instrument, Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), ...
SIM Surgical is a contract manufacturer of surgical instruments. Our product portfolio comprises of implants and instruments. more...
www.simsurgical.com | Send Inquiry | Phone: +1-(800)-521-2985
FDA Registration: 1935627 Year Established: 2001 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 13485 Certified
Products: Probes (FDA Code: HXB), Common Surgical Instrument, Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), ...
SIM Surgical is a contract manufacturer of surgical instruments. Our product portfolio comprises of implants and instruments. more...
Nexus Surgical, Inc. | Address: 711 South Carson St., Suite 4, Carson City, Nevada 89701, USA
Phone: +1-(775)-297-4300
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument (FDA Code: KDC), Manual Ophthalmic Instrument Table (FDA Code: HRK), Ophthalmic AC-Powered Operating Microscope and Accessories (FDA Code: HRM), ...
Nexus Surgical, Inc. provides disposable surgical instruments, electrosurgical cutting and coagulation devices and manual ophthalmic instrument tables. more...
Phone: +1-(775)-297-4300
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument (FDA Code: KDC), Manual Ophthalmic Instrument Table (FDA Code: HRK), Ophthalmic AC-Powered Operating Microscope and Accessories (FDA Code: HRM), ...
Nexus Surgical, Inc. provides disposable surgical instruments, electrosurgical cutting and coagulation devices and manual ophthalmic instrument tables. more...
Buxton Biomedical, Inc. | Address: 15a Melaine Lane, Unit 7, East Hanover, New Jersey 07936, USA
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Alto Development Corp. | Address: PO Box 758, Farmingdale, New Jersey 07727-3516, USA
www.aemedical.com | Send Inquiry | Phone: +1-(732)-938-2266
FDA Registration: 2242056 Year Established: 1968 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: Scissors, Suction Tubes, Dissectors, Wire Twisters (FDA Code: HXS), Aortic Punches, Electrode Cables (FDA Code: IKD), ...
Alto Development Corp. offers a wide variety of high quality medical products. We provide temporary cardiac pacing, sternotomy sutures, aortic punches, neuro and electro surgical products. We offer a more...
www.aemedical.com | Send Inquiry | Phone: +1-(732)-938-2266
FDA Registration: 2242056 Year Established: 1968 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: Scissors, Suction Tubes, Dissectors, Wire Twisters (FDA Code: HXS), Aortic Punches, Electrode Cables (FDA Code: IKD), ...
Alto Development Corp. offers a wide variety of high quality medical products. We provide temporary cardiac pacing, sternotomy sutures, aortic punches, neuro and electro surgical products. We offer a more...
Medin Corporation | Address: 90 Dayton Ave. Bldg. 16C, Passaic, New Jersey 07055, USA
www.medin.com | Send Inquiry | Phone: +1-(973)-779-2400/800-922-0476
Year Established: 1966 Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001-2000 Certified
Products: Surgical Retractor Systems (FDA Code: GAD), K-Wires, Sterilization Containers, Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), Steam Sterilizers (FDA Code: FLE), ...
Medin Corporation is a manufacturer of custom & standard instrument trays, cases and sterilization containers. Our product range includes ACT2™ container, K-Rak, laparoscopic rack, OSH trays and more...
www.medin.com | Send Inquiry | Phone: +1-(973)-779-2400/800-922-0476
Year Established: 1966 Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001-2000 Certified
Products: Surgical Retractor Systems (FDA Code: GAD), K-Wires, Sterilization Containers, Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), Steam Sterilizers (FDA Code: FLE), ...
Medin Corporation is a manufacturer of custom & standard instrument trays, cases and sterilization containers. Our product range includes ACT2™ container, K-Rak, laparoscopic rack, OSH trays and more...
Engineered Medical Solutions Co. LLC. | Address: 85 Industrial Dr., Building B, Phillipsburg, New Jersey 08865, USA
www.engineeredmedicalsolutions.com | Send Inquiry | Phone: +1-(908)-329-9123
FDA Registration: 3012973277 Quality: ISO 13485:2003 Certified
Products: Surgical Lamps (FDA Code: FTD), Surgical Retractor Systems (FDA Code: GAD), Surgical Lights (FDA Code: FTD), Surgical Retractor (FDA Code: GAD), Battery-Powered Medical Examination Light (FDA Code: KYT), Suction Catheter and Tip (FDA Code: JOL), ...
Engineered Medical Solutions Co. LLC. deals with surgical lighting. Our product categories are flat retractors, suction and zip-straps. Our Scintillant® retractor is a handheld surgical light asse more...
www.engineeredmedicalsolutions.com | Send Inquiry | Phone: +1-(908)-329-9123
FDA Registration: 3012973277 Quality: ISO 13485:2003 Certified
Products: Surgical Lamps (FDA Code: FTD), Surgical Retractor Systems (FDA Code: GAD), Surgical Lights (FDA Code: FTD), Surgical Retractor (FDA Code: GAD), Battery-Powered Medical Examination Light (FDA Code: KYT), Suction Catheter and Tip (FDA Code: JOL), ...
Engineered Medical Solutions Co. LLC. deals with surgical lighting. Our product categories are flat retractors, suction and zip-straps. Our Scintillant® retractor is a handheld surgical light asse more...
Greatbatch Medical, Inc., | Address: 10000 Wehrle Drive, Clarence, New York 14031, USA
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Drills, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Catheter Introducers (FDA Code: DYB), Interference Screws, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Drills, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Catheter Introducers (FDA Code: DYB), Interference Screws, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
Respiratory Science Industries Ltd | Address: 1325 M St., Elmont, New York 11003, USA
Phone: +1-(516)-561-6161
Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Surgical Retractor (FDA Code: GAD), ...
Respiratory Science Industries Ltd offers medical equipments, surgical tissue closure instruments, surgical measuring devices, retractors and surgical related products. more...
Phone: +1-(516)-561-6161
Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Surgical Retractor (FDA Code: GAD), ...
Respiratory Science Industries Ltd offers medical equipments, surgical tissue closure instruments, surgical measuring devices, retractors and surgical related products. more...
Sponsored Links
FDA Code / Regulation: GAD / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
