Surgical Instrument Tray Suppliers
Limit companies to: Worldwide USA
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, Catheter Introducers (FDA Code: DYB), ...
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, Catheter Introducers (FDA Code: DYB), ...
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...
DUX Dental | Address: 600 E. Hueneme Rd., Oxnard, California 93033-8600, USA
www.duxdental.com | Send Inquiry | Phone: +1-(805)-488-1122
Annual Revenues: USD 10-25 Million Quality: ISO 9000, CE Certified
Products: Needles, Radiation Protection - Lead-Free Gowns, Thermometers, Aprons, Bags, Wraps & Tubing, General Medical Supplies, ...
DUX Dental manufactures & markets dental products. We are an ISO 9000, CE MARK certified company. We offer products like restorative device, infection control, x-ray, accessories & prevention devices. more...
www.duxdental.com | Send Inquiry | Phone: +1-(805)-488-1122
Annual Revenues: USD 10-25 Million Quality: ISO 9000, CE Certified
Products: Needles, Radiation Protection - Lead-Free Gowns, Thermometers, Aprons, Bags, Wraps & Tubing, General Medical Supplies, ...
DUX Dental manufactures & markets dental products. We are an ISO 9000, CE MARK certified company. We offer products like restorative device, infection control, x-ray, accessories & prevention devices. 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, Forceps (FDA Code: HTD), External Bone Growth Stimulators, Bone Rasps (FDA Code: HTR), Surgical Helmet Systems, Ankle Braces, ...
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, Forceps (FDA Code: HTD), External Bone Growth Stimulators, Bone Rasps (FDA Code: HTR), Surgical Helmet Systems, Ankle Braces, ...
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: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
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: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
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: Prosthesis, Splints, Hip Positioner Systems, Leg Positioners, Casting Stands, Tibial Distractors, ...
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: Prosthesis, Splints, Hip Positioner Systems, Leg Positioners, Casting Stands, Tibial Distractors, ...
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...
Regeneration Technologies, Inc. | Address: 11621 Research Circle,P.O. Box 2650, Alachua, Florida 32616-2650, USA
www.rtix.com | Send Inquiry | Phone: +1-(386)-418-8888, 877-343-6832
FDA Registration: 3002719998 Year Established: 1998
Products: Allografts, Ophthalmology, Surgical Instrument Trays, Soft Tissue Allografts, Bone Allografts, Femoral Ring Allografts, Musculoskeletal Allografts, ...
Regeneration Technologies, Inc. renders tissue-based innovations that repair & promote the natural healing of human bone and other human tissues. We process human musculoskeletal & other tissues, incl more...
www.rtix.com | Send Inquiry | Phone: +1-(386)-418-8888, 877-343-6832
FDA Registration: 3002719998 Year Established: 1998
Products: Allografts, Ophthalmology, Surgical Instrument Trays, Soft Tissue Allografts, Bone Allografts, Femoral Ring Allografts, Musculoskeletal Allografts, ...
Regeneration Technologies, Inc. renders tissue-based innovations that repair & promote the natural healing of human bone and other human tissues. We process human musculoskeletal & other tissues, incl more...
Exactech, Inc. | Address: 2320 North West 66th Court, Gainesville, Florida 32653, USA
www.exac.com | Send Inquiry | Phone: +1-(352)-377-1140, 800-392-2832
FDA Registration: 1038671 Year Established: 1985 Annual Revenues: USD 50-100 Million Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Patellar Implants, Primary Femoral Implants, Bone Cement (FDA Code: LOD), Bone grafting Osteotomes, Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, ...
Exactech, Inc. is an orthopedic company that develops, manufactures, markets, distributes and sells orthopedic implant devices, related surgical instrumentation & biologic services to hospitals & phys more...
www.exac.com | Send Inquiry | Phone: +1-(352)-377-1140, 800-392-2832
FDA Registration: 1038671 Year Established: 1985 Annual Revenues: USD 50-100 Million Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Patellar Implants, Primary Femoral Implants, Bone Cement (FDA Code: LOD), Bone grafting Osteotomes, Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, ...
Exactech, Inc. is an orthopedic company that develops, manufactures, markets, distributes and sells orthopedic implant devices, related surgical instrumentation & biologic services to hospitals & phys 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
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: Vaginal Retractors (FDA Code: HDL), Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Freer Periosteal 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: Vaginal Retractors (FDA Code: HDL), Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Freer Periosteal 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...
Arthrex, Inc. | Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Interference Screws, Small Joint Arthroscopy Instruments, Small Joint Arthroscopy Instrument Sets, Endoscopic Carpal Tunnel Release Systems, Leg Positioners, Arthroscopes (FDA Code: HRX), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo more...
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Interference Screws, Small Joint Arthroscopy Instruments, Small Joint Arthroscopy Instrument Sets, Endoscopic Carpal Tunnel Release Systems, Leg Positioners, Arthroscopes (FDA Code: HRX), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo 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: Vaginal Retractors (FDA Code: HDL), Curettes, Forceps (FDA Code: HTD), Retractors, Hemostatic Mosquito Forceps, Bone Cutters, ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Forceps (FDA Code: HTD), Retractors, Hemostatic Mosquito Forceps, Bone Cutters, ...
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...
Halyard Health, Inc. | Address: 5405 Windward Parkway, Alpharetta, Georgia 30004, USA
https://www.halyardhealth.com | Phone: 844-HALYARD (425-9273)
FDA Registration: 3011270181 Year Established: 1903 Annual Revenues: > USD 1 Billion Employee Count: ~30 Quality: CE Certified
Products: Stethoscopes, Splints, Autoclaves, Forceps (FDA Code: HTD), Face Masks, Scrubs, ...
Halyard Health, Inc. is a consumer & medical products company. Its global tissue, personal care and health care brands include Huggies, Pull-Ups, Kotex, Depend, Kleenex, Scott, Kimwipes and WypAll. Ou more...
https://www.halyardhealth.com | Phone: 844-HALYARD (425-9273)
FDA Registration: 3011270181 Year Established: 1903 Annual Revenues: > USD 1 Billion Employee Count: ~30 Quality: CE Certified
Products: Stethoscopes, Splints, Autoclaves, Forceps (FDA Code: HTD), Face Masks, Scrubs, ...
Halyard Health, Inc. is a consumer & medical products company. Its global tissue, personal care and health care brands include Huggies, Pull-Ups, Kotex, Depend, Kleenex, Scott, Kimwipes and WypAll. Ou more...
Micrins, Inc. | Address: 28438 Ballard Drive, Lake Forest, Illinois 60045, USA
www.micrins.com | Send Inquiry | Phone: +1-(847)-549-1410
Year Established: 1987
Products: Elevators, Forceps (FDA Code: HTD), Mallets, Dressing Forceps, Jeweler Forceps, Dissectors, ...
Micrins, Inc. provides surgical instruments and equipment for plastic, micro & hand surgery. We offer a complete line of aesthetic and reconstructive surgical instrumentation. We offer products such a more...
www.micrins.com | Send Inquiry | Phone: +1-(847)-549-1410
Year Established: 1987
Products: Elevators, Forceps (FDA Code: HTD), Mallets, Dressing Forceps, Jeweler Forceps, Dissectors, ...
Micrins, Inc. provides surgical instruments and equipment for plastic, micro & hand surgery. We offer a complete line of aesthetic and reconstructive surgical instrumentation. We offer products such a 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: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
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: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
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...
Asico LLC | Address: 26 Plaza Drive, Westmont, Illinois 60559, USA
www.asico.com | Send Inquiry | Phone: +1-(630)-986-8032
FDA Registration: 1420491 Year Established: 1983 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Forceps (FDA Code: HTD), Surgical Marking Pens (FDA Code: HRP), Lacrimal Probes (FDA Code: HNL), Schepens Orbital Retractors, Titanium Ophthalmic Forceps, Lacrimal System, Cannulae, ...
Asico LLC produces ophthalmic surgical instruments. Our product range includes curettes, spatulas, hooks, manipulators, lens loops, spoons, pupil expanders, tension ring instruments, knives, blades, f more...
www.asico.com | Send Inquiry | Phone: +1-(630)-986-8032
FDA Registration: 1420491 Year Established: 1983 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Forceps (FDA Code: HTD), Surgical Marking Pens (FDA Code: HRP), Lacrimal Probes (FDA Code: HNL), Schepens Orbital Retractors, Titanium Ophthalmic Forceps, Lacrimal System, Cannulae, ...
Asico LLC produces ophthalmic surgical instruments. Our product range includes curettes, spatulas, hooks, manipulators, lens loops, spoons, pupil expanders, tension ring instruments, knives, blades, f more...
Paragon Medical, Inc. | Address: 8 Matchett Industrial Park Drive, Pierceton, Indiana 46562, USA
www.paragonmedical.com | Send Inquiry | Phone: +1-(574)-594-2140, 800-225-6975
FDA Registration: 1834331 Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~600 Quality: ISO 9001 Certified
Products: Probes (FDA Code: HXB), Procedure Trays, Bone Awls and Probes, Chemotherapy Containers, General Medical Supplies, Trays, ...
Paragon Medical, Inc. provides solutions for cases & trays, surgical instrumentation, and implantable components. ChromaSim is our tool for exploring our color options for cases & trays and surgical i more...
www.paragonmedical.com | Send Inquiry | Phone: +1-(574)-594-2140, 800-225-6975
FDA Registration: 1834331 Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~600 Quality: ISO 9001 Certified
Products: Probes (FDA Code: HXB), Procedure Trays, Bone Awls and Probes, Chemotherapy Containers, General Medical Supplies, Trays, ...
Paragon Medical, Inc. provides solutions for cases & trays, surgical instrumentation, and implantable components. ChromaSim is our tool for exploring our color options for cases & trays and surgical i more...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Orthopedic Cushions, Probes (FDA Code: HXB), Sutures, Old Plating Systems, Compression Hip Screw Systems, Plating Systems, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Orthopedic Cushions, Probes (FDA Code: HXB), Sutures, Old Plating Systems, Compression Hip Screw Systems, Plating Systems, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement 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, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
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, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
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...
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FDA Code / Regulation: FSM / 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.
