Disposable Surgical Instrument Suppliers
Limit companies to: Worldwide USA
Magnum Medical Sales, Inc. | Address: 395 Josefa St, San Jose, California 95126, USA 
www.magnummedical.net | Send Inquiry | Phone: +1-(408)-294-1397
FDA Registration: 1421307 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Maintenance & Repair, Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), General Surgical Manual Instrument (FDA Code: MDM), ENT Manual Surgical Instrument (FDA Code: LRC), Laryngoscope/Nasopharyngoscope (FDA Code: EQN), ...
Magnum Medical Sales, Inc. performs system maintenance, leak testing and installation of new med-gas systems. We also render repairing services for portable analgesia machines and regulators. more...
www.magnummedical.net | Send Inquiry | Phone: +1-(408)-294-1397
FDA Registration: 1421307 Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Maintenance & Repair, Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), General Surgical Manual Instrument (FDA Code: MDM), ENT Manual Surgical Instrument (FDA Code: LRC), Laryngoscope/Nasopharyngoscope (FDA Code: EQN), ...
Magnum Medical Sales, Inc. performs system maintenance, leak testing and installation of new med-gas systems. We also render repairing services for portable analgesia machines and regulators. 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...
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: Colposcopes, Disposable Examination Gloves, Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Incubators, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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: Colposcopes, Disposable Examination Gloves, Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Incubators, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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...
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, Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
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, Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
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...
Hospira, Inc. | Address: 275 N. Field Dr., Lake Forest, Illinois 60045, USA
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Masks & Breathing Bags, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Irrigating Solutions, Integrated Anesthesia Machines, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Masks & Breathing Bags, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Irrigating Solutions, Integrated Anesthesia Machines, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in 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...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
Aspen Surgical Products | Address: 6945 Southbelt Dr. SE, Caledonia, Michigan 49316, USA
www.aspensurgical.com | Send Inquiry | Phone: +1-(616)-698-7100, 888-364-7004
FDA Registration: 1836161 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Umbilical Cord Clamps, Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Skin Closure Adhesive Strips (FDA Code: FPX), ...
Aspen Surgical Products deals with medical products. We are an ISO: 13485 certified and FDA-registered facility We carry an extensive line of products including operating room disposables, wound care more...
www.aspensurgical.com | Send Inquiry | Phone: +1-(616)-698-7100, 888-364-7004
FDA Registration: 1836161 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Umbilical Cord Clamps, Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Skin Closure Adhesive Strips (FDA Code: FPX), ...
Aspen Surgical Products deals with medical products. We are an ISO: 13485 certified and FDA-registered facility We carry an extensive line of products including operating room disposables, wound care more...
Scanlan International | Address: One Scanlan Plaza, St. Paul, Minnesota 55107, USA
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scissors, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scissors, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
St. Jude Medical, Inc. | Address: One Lillehei Plaza, St. Paul, Minnesota 55117-9983, USA
www.sjm.com | Phone: +1-(651)-483-2000, 800-328-9634
FDA Registration: 2017865 Quality: ISO 9001, ISO 9002, CE Certified
Products: Mechanical Aortic Valves, Single chamber ICD, Pacemaker Generators, Guidewires, Hydrosteer, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, ...
St.Jude Medical, Inc. delivers implantable bradycardia, cardiac surgical, electrophysiology, implant cardiac monitors, repair, tachycardia, tissue valves, spinal cord stimulation, patient care network more...
www.sjm.com | Phone: +1-(651)-483-2000, 800-328-9634
FDA Registration: 2017865 Quality: ISO 9001, ISO 9002, CE Certified
Products: Mechanical Aortic Valves, Single chamber ICD, Pacemaker Generators, Guidewires, Hydrosteer, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, ...
St.Jude Medical, Inc. delivers implantable bradycardia, cardiac surgical, electrophysiology, implant cardiac monitors, repair, tachycardia, tissue valves, spinal cord stimulation, patient care network 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...
Medical Action Industries Inc. | Address: 800 Prime Place, Hauppauge, New York 11788, USA
www.medical-action.com | Send Inquiry | Phone: +1-(631)-231-4600
FDA Registration: 1030451 Year Established: 1977
Products: Autoclaves, Surgical Marking Pens (FDA Code: HRP), Sterilizing Aids, Diagnostic Aids, Analgesics, Antibiotics & Antibacterials, ...
Medical Action Industries Inc. develops & distributes a variety of disposable surgical-related products. We manufacture & distribute operating room disposable supplies, containment systems for medical more...
www.medical-action.com | Send Inquiry | Phone: +1-(631)-231-4600
FDA Registration: 1030451 Year Established: 1977
Products: Autoclaves, Surgical Marking Pens (FDA Code: HRP), Sterilizing Aids, Diagnostic Aids, Analgesics, Antibiotics & Antibacterials, ...
Medical Action Industries Inc. develops & distributes a variety of disposable surgical-related products. We manufacture & distribute operating room disposable supplies, containment systems for medical 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...
Valley Forge Scientific Corp. | Address: 3600 Horizon Drive, King of Prussia, Pennsylvania 19406, USA
www.vlfg.com | Send Inquiry | Phone: +1-(484)-690-9000, 800-469-6369
FDA Registration: 2521567 Year Established: 1980 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Cutting Loops, Bipolar Coagulator System, Bipolar Electrosurgery System, Directional Suction Irrigator, Suction Irrigator, Adjustable Operating Room Stool (FDA Code: FZM), ...
Valley Forge Scientific Corp. develops and manufactures bipolar electrosurgical systems & related instrumentation. Our products include ophthalmology, neurosurgery, ear, nose, and throat. Our DualWave more...
www.vlfg.com | Send Inquiry | Phone: +1-(484)-690-9000, 800-469-6369
FDA Registration: 2521567 Year Established: 1980 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Cutting Loops, Bipolar Coagulator System, Bipolar Electrosurgery System, Directional Suction Irrigator, Suction Irrigator, Adjustable Operating Room Stool (FDA Code: FZM), ...
Valley Forge Scientific Corp. develops and manufactures bipolar electrosurgical systems & related instrumentation. Our products include ophthalmology, neurosurgery, ear, nose, and throat. Our DualWave more...
Surgistar Inc. | Address: 820 Corridor Park Blvd, Knoxville, Tennessee 37932, USA
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Laparoscopic Equipment, Cystotome Needles, Microkeratome Blades, Sickle Blades, MVR Blades, Trabeculectomy Blades, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
www.surgistar.com | Send Inquiry | Phone: +1-(865)-671-4300
FDA Registration: 2028661 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Laparoscopic Equipment, Cystotome Needles, Microkeratome Blades, Sickle Blades, MVR Blades, Trabeculectomy Blades, ...
Surgistar, Inc. is a manufacturer of single use ophthalmic, ENT and surgical products. Our ophthalmology products include knives, blades, cannulas, microkeratome blades, tubing, and corneal trephines. more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Chase Medical | Address: 1876 Firman Drive, Richardson, Texas 75081, USA
www.chasemedical.com | Send Inquiry | Phone: +1-(972)-783-0644, 800-787-0378
FDA Registration: 1649139
Products: Left Ventricle Restoration, General Medical Supplies, Surface Disinfectants, Left Ventricle Restoration Standard, Cardiovascular Surgical Instrument (FDA Code: DWS), Cardiopulmonary Bypass Accessories (FDA Code: KRI), ...
Chase Medical designs & manufactures products for the comprehensive surgical treatment of congestive heart failure, including products for surgical ventricular restoration procedures and for both beat more...
www.chasemedical.com | Send Inquiry | Phone: +1-(972)-783-0644, 800-787-0378
FDA Registration: 1649139
Products: Left Ventricle Restoration, General Medical Supplies, Surface Disinfectants, Left Ventricle Restoration Standard, Cardiovascular Surgical Instrument (FDA Code: DWS), Cardiopulmonary Bypass Accessories (FDA Code: KRI), ...
Chase Medical designs & manufactures products for the comprehensive surgical treatment of congestive heart failure, including products for surgical ventricular restoration procedures and for both beat more...
Hewit Medical | Address: 6200 South Mcclintock , Suit 109, Tempe, Arizona 85283, USA
Phone: +1-(480)-777-7005
Products: General Surgical Instruments, Common Surgical Instrument, Disposable Surgical Instrument (FDA Code: KDC), General Surgical Manual Instrument (FDA Code: MDM), ...
Hewit Medical specializes in manufacturing surgical and medical instruments. more...
Phone: +1-(480)-777-7005
Products: General Surgical Instruments, Common Surgical Instrument, Disposable Surgical Instrument (FDA Code: KDC), General Surgical Manual Instrument (FDA Code: MDM), ...
Hewit Medical specializes in manufacturing surgical and medical instruments. more...
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FDA Code / Regulation: KDC / 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.
