Instrument Surgical Guide Suppliers
Limit companies to: Worldwide USA
W. l. Gore & Associates, Inc. | Address: P.O. Box 2400, Flagstaff, Arizona 86003-2400, USA 
www.goremedical.com | Send Inquiry | Phone: +1-(928)-779-2771, 800 -437-8181
FDA Registration: 3013164176
Products: Sutures, Dural Substitute, Catheter Introducers (FDA Code: DYB), Cruciate Ligament Tool, Vascular Grafts, Surgical Patches, ...
W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a more...
www.goremedical.com | Send Inquiry | Phone: +1-(928)-779-2771, 800 -437-8181
FDA Registration: 3013164176
Products: Sutures, Dural Substitute, Catheter Introducers (FDA Code: DYB), Cruciate Ligament Tool, Vascular Grafts, Surgical Patches, ...
W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a more...
Depuy Orthopaedics, Inc. | Address: 4240 Holden Street, Emeryville, California 94608, USA
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Allografts, Hydroxyapatite, Autologous Platelet Gel Preparation Systems, Disc Replacements, ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Allografts, Hydroxyapatite, Autologous Platelet Gel Preparation Systems, Disc Replacements, ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
Advanced Bionics Corporation | Address: 12740 San Fernando Road, Sylmar, California 91342, USA
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Batteries, Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Magnetic Stimulators, Urethral Catheters (FDA Code: GBM), ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Batteries, Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Magnetic Stimulators, Urethral Catheters (FDA Code: GBM), ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to 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...
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...
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...
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...
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...
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: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Skull Clamps and Pins, Synthetic Spacers, Occipital Fixation Systems, ...
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: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Skull Clamps and Pins, Synthetic Spacers, Occipital Fixation Systems, ...
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, Surgical Retractor Systems (FDA Code: GAD), Orthoses, Humeral Splints, Foot Support, Drill Bit (FDA Code: HTW), ...
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, Surgical Retractor Systems (FDA Code: GAD), Orthoses, Humeral Splints, Foot Support, Drill Bit (FDA Code: HTW), ...
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...
Blackstone Medical, Inc. | Address: 90 Brookdale Drive, Springfield, Massachusetts 01104, USA
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Probes (FDA Code: HXB), Posterior, Plating Systems, Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Bio Absorbable Plating Systems, ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Probes (FDA Code: HXB), Posterior, Plating Systems, Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Bio Absorbable Plating Systems, ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
AGA Medical Corporation | Address: 5050 Nathan Lane North, Plymouth, Minnesota 55442, USA
www.amplatzer.com | Send Inquiry | Phone: +1-(763)-513-9227
FDA Registration: 2135147 Year Established: 1996 Employee Count: ~200 Quality: ISO, CE Certified
Products: PFO Closure Devices, PDA Closure Devices, Transcatheter Occlusion Device, PDA Closure Devices, Non-Surgical Closure, PDA Closure Devices, Patent Ductus Arteriosus, PDA Closure Devices, Duct Occluder, PDA Closure Devices, ...
AGA Medical Corporation specializes in medical devices for use in cardiovascular applications. We treat congenital and structural heart defects using non-surgical techniques. Our patented Amplatzer li more...
www.amplatzer.com | Send Inquiry | Phone: +1-(763)-513-9227
FDA Registration: 2135147 Year Established: 1996 Employee Count: ~200 Quality: ISO, CE Certified
Products: PFO Closure Devices, PDA Closure Devices, Transcatheter Occlusion Device, PDA Closure Devices, Non-Surgical Closure, PDA Closure Devices, Patent Ductus Arteriosus, PDA Closure Devices, Duct Occluder, PDA Closure Devices, ...
AGA Medical Corporation specializes in medical devices for use in cardiovascular applications. We treat congenital and structural heart defects using non-surgical techniques. Our patented Amplatzer li more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Otoscopes, Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Laryngoscopes, Lacrimal Dilators and Cannulas, Dressing Forceps, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Otoscopes, Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Laryngoscopes, Lacrimal Dilators and Cannulas, Dressing Forceps, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Guidewire Technologies, Inc. | Address: 26 Keewaydin Drive Unit A, Salem, New Hampshire 03079, USA
guidewiretech.com | Send Inquiry | Phone: +1-(603)-894-4399
FDA Registration: 1221806 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~30
Products: Guidewires, Peripheral Guidewires, Guidewires "J" Shaped, Guidewire Catheter (FDA Code: DQX), Angioplasty Guidewire, Instrument Surgical Guide (FDA Code: FZX), ...
Guidewire Technologies, Inc. offers medical guidewires. Our guidewires come in standard, fixed core, and custom designs. Our capabilities include spring winding, grinding, welding, marking, j-tip form more...
guidewiretech.com | Send Inquiry | Phone: +1-(603)-894-4399
FDA Registration: 1221806 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~30
Products: Guidewires, Peripheral Guidewires, Guidewires "J" Shaped, Guidewire Catheter (FDA Code: DQX), Angioplasty Guidewire, Instrument Surgical Guide (FDA Code: FZX), ...
Guidewire Technologies, Inc. offers medical guidewires. Our guidewires come in standard, fixed core, and custom designs. Our capabilities include spring winding, grinding, welding, marking, j-tip form more...
Gotham Medical LLC | Address: 725 River Road, Suite 32-254, Edgewater, New Jersey 07020, USA
www.gothammedical.com | Send Inquiry | Phone: +1-(201)-608-7169
Products: Femuroral Intramedullary Nails, Bone Taps (FDA Code: HWX), Orthopaedic Trauma & Clinical Therapies, Wire Cutters (FDA Code: HXZ), Bone Mill (FDA Code: LYS), Fibula Plates, ...
Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and t more...
www.gothammedical.com | Send Inquiry | Phone: +1-(201)-608-7169
Products: Femuroral Intramedullary Nails, Bone Taps (FDA Code: HWX), Orthopaedic Trauma & Clinical Therapies, Wire Cutters (FDA Code: HXZ), Bone Mill (FDA Code: LYS), Fibula Plates, ...
Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and t more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Ethicon Endo-Surgery, Inc. | Address: 4545 Creek Road, Cincinnati, Ohio 45242-2839, USA
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Tissue Forceps, ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Tissue Forceps, ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
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FDA Code / Regulation: FZX / 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.
