Surgical Retractor Systems Suppliers
Surgical retractor system is used for holding tissue away from a surgical site during a medical or dental procedure. The surgical retractor system comprises of a tubular member such as a cannula and a retractor member.
Limit companies to: Worldwide USA
Byron Medical, Inc. | Address: 602 W. Rillito, Tucson, Arizona 85705, USA 
www.byrondirect.com | Send Inquiry | Phone: +1-(520)-573-0857, 800-777-3434
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Desmarres Lid Retractors, Jaeger Lid Plates, Goggles & Protective Eyewear, IV Catheters & Infusion Sets, General Medical Supplies, General Surgical Aids, ...
Byron Medical, Inc. introduced ActiPatch™, which is a new innovation in micro electrical therapy. Our alpha infusion pumps comes in two sizes, the 200ml and the 450 ml, thus offering the physici more...
www.byrondirect.com | Send Inquiry | Phone: +1-(520)-573-0857, 800-777-3434
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Desmarres Lid Retractors, Jaeger Lid Plates, Goggles & Protective Eyewear, IV Catheters & Infusion Sets, General Medical Supplies, General Surgical Aids, ...
Byron Medical, Inc. introduced ActiPatch™, which is a new innovation in micro electrical therapy. Our alpha infusion pumps comes in two sizes, the 200ml and the 450 ml, thus offering the physici more...
Edwards Lifesciences Corporation | Address: One Edwards Way, Irvine, California 92614, USA
www.edwards.com | Send Inquiry | Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958 Annual Revenues: USD 1-5 Million Employee Count: ~5600 Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a more...
www.edwards.com | Send Inquiry | Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958 Annual Revenues: USD 1-5 Million Employee Count: ~5600 Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a more...
DJ Orthopedics Inc. | Address: 2985 Scott Street, Vista, California 92081, USA
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, External Bone Growth Stimulators, Back Braces & Supports, Centrifuges, Aspirators, Casting Materials, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, External Bone Growth Stimulators, Back Braces & Supports, Centrifuges, Aspirators, Casting Materials, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Innovative Medical Products, Inc | Address: 87 Spring Lane, Plainville, Connecticut 06062, USA
www.innovativemedical.com | Send Inquiry | Phone: +1-(860)-793-0391
FDA Registration: 1223419 Year Established: 1983 Quality: CE Certified
Products: Splints, Hip Positioner Systems, Leg Positioners, Casting Stands, Tibial Distractors, Casting Materials, ...
Innovative Medical Products, Inc specializes in the areas of orthopaedic surgery, radiology, anesthesia and home healthcare. We offer products such as hip positioners, knee positioners, shoulder posit more...
www.innovativemedical.com | Send Inquiry | Phone: +1-(860)-793-0391
FDA Registration: 1223419 Year Established: 1983 Quality: CE Certified
Products: Splints, Hip Positioner Systems, Leg Positioners, Casting Stands, Tibial Distractors, Casting Materials, ...
Innovative Medical Products, Inc specializes in the areas of orthopaedic surgery, radiology, anesthesia and home healthcare. We offer products such as hip positioners, knee positioners, shoulder posit more...
Cooper Surgical, Inc. | Address: 95 Corporate Drive, Trumbul, Connecticut 06611, USA
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
Clinimed, Inc. | Address: 303 Markus Court, Sandy Brae Industrial Park, Newark, Delaware 19713-1190, USA
www.clinimed.us | Send Inquiry | Phone: +1-(302)-454-8400
FDA Registration: 2431788 Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: Tourniquet Machines, Tourniquets, Pneumatic Tourniquet (FDA Code: KCY), Tourniquet System, Tourniquet machines and accessories, Orthopedic tourniquet machines, ...
Clinimed Inc. deals with surgical instruments and medical devices. We supply clinimed tourniquete, halo retractors and vein strippers. We offer online journals such as anesthesiology, cancer, cardiolo more...
www.clinimed.us | Send Inquiry | Phone: +1-(302)-454-8400
FDA Registration: 2431788 Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: Tourniquet Machines, Tourniquets, Pneumatic Tourniquet (FDA Code: KCY), Tourniquet System, Tourniquet machines and accessories, Orthopedic tourniquet machines, ...
Clinimed Inc. deals with surgical instruments and medical devices. We supply clinimed tourniquete, halo retractors and vein strippers. We offer online journals such as anesthesiology, cancer, cardiolo more...
Southpointe Surgical Supply, Inc. | Address: 166 NW 110 Way, Coral Springs, Florida 33071, USA
www.southpointesurgical.com | Send Inquiry | Phone: +1-(954)-636-9960, 877-625-2309
Products: Anesthesia Equipment, Absorbable Sutures (FDA Code: GAK), Anesthesia Equipment, Abdominal Retractor, Amniocentesis Tray, Alligator Ear Forceps, ...
Southpointe Surgical Supply, Inc. provides a complete collection of surgical instruments and related surgical products that are used in hospitals & private practices. Our products include blood drawin more...
www.southpointesurgical.com | Send Inquiry | Phone: +1-(954)-636-9960, 877-625-2309
Products: Anesthesia Equipment, Absorbable Sutures (FDA Code: GAK), Anesthesia Equipment, Abdominal Retractor, Amniocentesis Tray, Alligator Ear Forceps, ...
Southpointe Surgical Supply, Inc. provides a complete collection of surgical instruments and related surgical products that are used in hospitals & private practices. Our products include blood drawin more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Anspach Effort, Inc. | Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410, USA
www.anspach.com | Send Inquiry | Phone: +1-(561)-627-1080,800-327-6887
FDA Registration: 1045834
Products: Pneumatic Neurosurgical Drill Systems, Electric Neurosurgical Drill Systems, Tens Electric Heating Pads, Electrical Equipment For Laboratory, Electric Massagers, Thermophore Electric Moist Heating Pad, ...
Anspach Effort, Inc. manufactures high-speed instrumentation for neurosurgery, neurotology, otology & orthopaedics. Our XMax high performance system provides a perfect pneumatic system to handle a com more...
www.anspach.com | Send Inquiry | Phone: +1-(561)-627-1080,800-327-6887
FDA Registration: 1045834
Products: Pneumatic Neurosurgical Drill Systems, Electric Neurosurgical Drill Systems, Tens Electric Heating Pads, Electrical Equipment For Laboratory, Electric Massagers, Thermophore Electric Moist Heating Pad, ...
Anspach Effort, Inc. manufactures high-speed instrumentation for neurosurgery, neurotology, otology & orthopaedics. Our XMax high performance system provides a perfect pneumatic system to handle a com more...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
Elmed Inc. | Address: 60 West fay avenue, Addison, Illinois 60101, USA
www.elmed.com | Send Inquiry | Phone: +1-(630)-543-2792
FDA Registration: 1412854 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Monopolar Aids, Foot Switching, Handswitching, Monopolar Generators, Generators, Anterior Cruciate Ligament Surgical Reconstruction System, ...
Elmed Inc. specializes in reusable electrosurgical equipment & accessories. We are involved in monopolar electrosurgical technology. Our retract robot is designed to assist surgeons during intensive p more...
www.elmed.com | Send Inquiry | Phone: +1-(630)-543-2792
FDA Registration: 1412854 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Monopolar Aids, Foot Switching, Handswitching, Monopolar Generators, Generators, Anterior Cruciate Ligament Surgical Reconstruction System, ...
Elmed Inc. specializes in reusable electrosurgical equipment & accessories. We are involved in monopolar electrosurgical technology. Our retract robot is designed to assist surgeons during intensive p more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Life Instrument Corporation | Address: 14 Wood Rd. Suite 002, Braintree, Massachusetts 02184, USA
www.lifeinstruments.com | Phone: +1-(781)-849-0109, 800-925-2995
FDA Registration: 1222188
Products: Curettes, Forceps (FDA Code: HTD), Freer Periosteal Elevators, Penfield Dissectors, Suction Tubes, Bayonet, ...
Life Instrument Corporation serves neuro surgeons and orthopedic surgeons with surgical instruments. Our products include spinal instruments and orthopedic instruments. The spinal & orthopedic instrum more...
www.lifeinstruments.com | Phone: +1-(781)-849-0109, 800-925-2995
FDA Registration: 1222188
Products: Curettes, Forceps (FDA Code: HTD), Freer Periosteal Elevators, Penfield Dissectors, Suction Tubes, Bayonet, ...
Life Instrument Corporation serves neuro surgeons and orthopedic surgeons with surgical instruments. Our products include spinal instruments and orthopedic instruments. The spinal & orthopedic instrum more...
Depuy Spine, Inc. | Address: 325 Paramount Drive, Raynham, Massachusetts 02767, USA
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
OMNI life science, Inc. | Address: 175 Paramount dr., Raynham, Massachusetts 02767, USA
www.omnils.com | Send Inquiry | Phone: +1-(508)-824-2444
Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 13485 ,CE Certification, MDSS Certification Certified
Products: Humeral Splints, Lower Extremity Splints, Orthoses, Humeral Splints, Adjustable Ankle Support, Air Ankle Support, Ankle Support, ...
Omni Life Science designs, produces and distributes orthotic devices. We specialize in knee bracing and measurement systems. We offer products like hip & knee reconstruction. Our Apex Modular™ f more...
www.omnils.com | Send Inquiry | Phone: +1-(508)-824-2444
Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 13485 ,CE Certification, MDSS Certification Certified
Products: Humeral Splints, Lower Extremity Splints, Orthoses, Humeral Splints, Adjustable Ankle Support, Air Ankle Support, Ankle Support, ...
Omni Life Science designs, produces and distributes orthotic devices. We specialize in knee bracing and measurement systems. We offer products like hip & knee reconstruction. Our Apex Modular™ f more...
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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.
