General Surgical Manual Instrument Suppliers
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...
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: Acetabular Liners, AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), AC-Powered Surgical Instrument Motor (FDA Code: GEY), 3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Acetabular Mesh Hip Prosthesis (FDA Code: JDJ), ...
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: Acetabular Liners, AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), AC-Powered Surgical Instrument Motor (FDA Code: GEY), 3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Acetabular Mesh Hip Prosthesis (FDA Code: JDJ), ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. 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...
Abbott Vascular Devices | Address: 400 Saginaw Drive, Redwood City, California 94063-4749, USA
www.abbottvasculardevices.com | Phone: +1-(650)-474-3000
Year Established: 1888
Products: Active Closure Devices, Cardiac Bypass Assist Tools, Heart Stabilization Tools, Peripheral Guidewires, Carotid Stent Systems (FDA Code: NIM), Embolic Protection System, Angiographic Catheter, El Gamal Sones, ...
Abbott Vascular Devices concentrates on medical device innovations with world-class pharmaceuticals to deliver solutions for the treatment of vascular diseases. We render a portfolio of endovascular p more...
www.abbottvasculardevices.com | Phone: +1-(650)-474-3000
Year Established: 1888
Products: Active Closure Devices, Cardiac Bypass Assist Tools, Heart Stabilization Tools, Peripheral Guidewires, Carotid Stent Systems (FDA Code: NIM), Embolic Protection System, Angiographic Catheter, El Gamal Sones, ...
Abbott Vascular Devices concentrates on medical device innovations with world-class pharmaceuticals to deliver solutions for the treatment of vascular diseases. We render a portfolio of endovascular p more...
Laserscope | Address: 3070 Orchard Drive, San Jose, California 95134-2011, USA
www.laserscope.com | Send Inquiry | Phone: +1-(408)-943-0636, (800)-356-7600
FDA Registration: 2937094 Year Established: 1984 Annual Revenues: USD 100-500 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Dermatological Equipment, Cosmetic Lasers, Powered Surgical Laser Instrument (FDA Code: GEX), Cosmetic Lasers, Contact/non contact mode, Hair Removal Device, Hair Removal Kits, ...
Laserscope focuses on pelvic health. We offer solutions for men and women in the areas of urinary incontinence, fecal incontinence, vaginal prolapse treatment, uterine health, erectile restoration, an more...
www.laserscope.com | Send Inquiry | Phone: +1-(408)-943-0636, (800)-356-7600
FDA Registration: 2937094 Year Established: 1984 Annual Revenues: USD 100-500 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Dermatological Equipment, Cosmetic Lasers, Powered Surgical Laser Instrument (FDA Code: GEX), Cosmetic Lasers, Contact/non contact mode, Hair Removal Device, Hair Removal Kits, ...
Laserscope focuses on pelvic health. We offer solutions for men and women in the areas of urinary incontinence, fecal incontinence, vaginal prolapse treatment, uterine health, erectile restoration, an more...
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...
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: Magnetic Stimulators, Commercial Magnetic Stimulators, Bio-Magnetic Stimulators, Non-Invasive Magnetic Stimulators, Water Vooled Magnetic Stimulators, Hearing Aid Batteries and Accessories, ...
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: Magnetic Stimulators, Commercial Magnetic Stimulators, Bio-Magnetic Stimulators, Non-Invasive Magnetic Stimulators, Water Vooled Magnetic Stimulators, Hearing Aid Batteries and Accessories, ...
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...
Sakura Finetek U.S.A., Inc. | Address: 1750 West 214th Street, Torrance, California 90501, USA
www.sakura-americas.com | Send Inquiry | Phone: +1-(310)-972-7800, 800-725-8723
FDA Registration: 2083544
Products: Cryostat Equipment, Microtome Equipment, Cytology Equipment Processing & Embedding, Cytology Equipment Stainers, Cytology Test Kits, Cytology Test Stains, ...
Sakura Finetek U.S.A., Inc. provides ingenious solutions to the real laboratories. Our products include embedding, microtomy, storage, cassettes, cytology, immunohistochemistry, and primary & special more...
www.sakura-americas.com | Send Inquiry | Phone: +1-(310)-972-7800, 800-725-8723
FDA Registration: 2083544
Products: Cryostat Equipment, Microtome Equipment, Cytology Equipment Processing & Embedding, Cytology Equipment Stainers, Cytology Test Kits, Cytology Test Stains, ...
Sakura Finetek U.S.A., Inc. provides ingenious solutions to the real laboratories. Our products include embedding, microtomy, storage, cassettes, cytology, immunohistochemistry, and primary & special more...
Novo Engineering | Address: 1350 Specialty Drive, Suite A, Vista, California 92081-8522, USA
https://novoengineering.com | Send Inquiry | Phone: +1-(760)-598-6686
Products: Biomedical Device Consulting, Biomedical Monitoring Device Development, Medical Device Contract Manufacturing, Class I and II Medical Device Manufacturing Services, Custom Designed Medical Devices, Medical Device Consulting, ...
Novo Engineering specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO-certified (ISO 13485-2003) quality management system (QMS) cove more...
https://novoengineering.com | Send Inquiry | Phone: +1-(760)-598-6686
Products: Biomedical Device Consulting, Biomedical Monitoring Device Development, Medical Device Contract Manufacturing, Class I and II Medical Device Manufacturing Services, Custom Designed Medical Devices, Medical Device Consulting, ...
Novo Engineering specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO-certified (ISO 13485-2003) quality management system (QMS) cove more...
Sontec Instruments, Inc. | Address: 7248 South Tucson Way, Colorado 80112, USA
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica 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...
Schueler & Company Inc | Address: PO Box 528, Stratford, Connecticut 06615-052, USA
www.schuelerinc.com | Send Inquiry | Phone: +1-(516)-487-1500
Annual Revenues: USD 1-5 Million Quality: ISO 9000, CE Certified
Products: General Diagnostic Supplies, Dental X-Ray Film, X-Ray Film Holder, Blue Rare Earth X-Ray Film, Bench Mounted Hopper for X-Ray Film, Radiographic X-Ray Film, ...
Schueler & Company Inc markets and specializes in the medical & surgical field. We represent over 100 U.S. manufacturers. We deal in the most appropriate medical equipment and locate the right source more...
www.schuelerinc.com | Send Inquiry | Phone: +1-(516)-487-1500
Annual Revenues: USD 1-5 Million Quality: ISO 9000, CE Certified
Products: General Diagnostic Supplies, Dental X-Ray Film, X-Ray Film Holder, Blue Rare Earth X-Ray Film, Bench Mounted Hopper for X-Ray Film, Radiographic X-Ray Film, ...
Schueler & Company Inc markets and specializes in the medical & surgical field. We represent over 100 U.S. manufacturers. We deal in the most appropriate medical equipment and locate the right source 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...
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...
Arthrex, Inc. | Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
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: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
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...
Medone Surgical, Inc. | Address: 670 Tallevast Road, Sarasota, Florida 34243, USA
www.medone.com | Send Inquiry | Phone: +1-(941)-359-3129, 866-633-6631
FDA Registration: 3014197664
Products: Retinal Brushes, Vertical Microscissors, Angled Micro Capsulorhexis Forceps, Neurosurgery, Rotary Instruments, Titanium Micro Forceps, Micro Scissors, ...
Medone Surgical, Inc. manufactures & markets surgical products. We are an ISO certified company. We offer products for retina surgery, cannulas related accessory products, including FlexTip™Cann more...
www.medone.com | Send Inquiry | Phone: +1-(941)-359-3129, 866-633-6631
FDA Registration: 3014197664
Products: Retinal Brushes, Vertical Microscissors, Angled Micro Capsulorhexis Forceps, Neurosurgery, Rotary Instruments, Titanium Micro Forceps, Micro Scissors, ...
Medone Surgical, Inc. manufactures & markets surgical products. We are an ISO certified company. We offer products for retina surgery, cannulas related accessory products, including FlexTip™Cann more...
Conkin Surgical Instruments Ltd. | Address: 1020 Greensboro Road, NE, Eatonton, Georgia 31024, USA
Phone: +1-(800)-535-8073
FDA Registration: 8022078 Year Established: 1974 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Uterine Mobilizer, Needle Introducer & Knot Pusher, Vaginal Delineator, Uterine Elevator (FDA Code: HDP), Plastic Surgery Kit and Accessories (FDA Code: FTN), Uterine Manipulator Injector & Accessories, ...
Conkin Surgical Instruments Ltd. offers laparoscopical, pelviscopical and gynecological surgical instruments such as uterine mobilizers & manipulators & balloon cannula. more...
Phone: +1-(800)-535-8073
FDA Registration: 8022078 Year Established: 1974 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Uterine Mobilizer, Needle Introducer & Knot Pusher, Vaginal Delineator, Uterine Elevator (FDA Code: HDP), Plastic Surgery Kit and Accessories (FDA Code: FTN), Uterine Manipulator Injector & Accessories, ...
Conkin Surgical Instruments Ltd. offers laparoscopical, pelviscopical and gynecological surgical instruments such as uterine mobilizers & manipulators & balloon cannula. 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...
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, Dressing Forceps, Dissectors, Backhaus Towel Forceps, Dilators, Endoscopic Facelift Elevator, ...
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, Dressing Forceps, Dissectors, Backhaus Towel Forceps, Dilators, Endoscopic Facelift Elevator, ...
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...
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FDA Code / Regulation: MDM / 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.
