Scalpel Handle 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...
ArosurgicalT Instruments Corporation | Address: 220 Newport Center Drive, Suite 11101, Newport Beach, California 92660, USA
www.arosurgical.com | Send Inquiry | Phone: +1-(949)-640-9932
FDA Registration: 2085887 Year Established: 1992
Products: Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Non-Absorbable Sutures (FDA Code: GAO), Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, ...
Arosurgical™ Instruments Corporation distributes single use micro vessel clamps. We are the exclusive distributor of the Bear™ micro vessel clamps. We offer products like AROS micro suture more...
www.arosurgical.com | Send Inquiry | Phone: +1-(949)-640-9932
FDA Registration: 2085887 Year Established: 1992
Products: Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Non-Absorbable Sutures (FDA Code: GAO), Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, ...
Arosurgical™ Instruments Corporation distributes single use micro vessel clamps. We are the exclusive distributor of the Bear™ micro vessel clamps. We offer products like AROS micro suture more...
KCK Medical | Address: 14941 Calvert Street, Van Nuys, California 91411, USA
www.kckmedical.com | Send Inquiry | Phone: +1-(818)-997-8574, 888-880-1967
Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Urethral (Foley) Catheters, Urinary Leg Bags, Incontinence Cuffs, Blood Collection Needles, Blood pressure Cuffs (FDA Code: DXQ), Wound Dressings Medicated Bandages, ...
KCK Medical offers medical supplies for private individuals, home health caregivers, nurses and doctors. We provide a wide variety of urological products including Bard, Mentor, Rusch, Rochester, Holl more...
www.kckmedical.com | Send Inquiry | Phone: +1-(818)-997-8574, 888-880-1967
Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Urethral (Foley) Catheters, Urinary Leg Bags, Incontinence Cuffs, Blood Collection Needles, Blood pressure Cuffs (FDA Code: DXQ), Wound Dressings Medicated Bandages, ...
KCK Medical offers medical supplies for private individuals, home health caregivers, nurses and doctors. We provide a wide variety of urological products including Bard, Mentor, Rusch, Rochester, Holl 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...
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...
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...
Brasseler USA | Address: 1 Brasseler Boulevard, Savannah, Georgia 31419, USA
www.brasselerusamedical.com | Send Inquiry | Phone: +1-(800)-535-6638
FDA Registration: 2025102 Year Established: 1987 Employee Count: ~150 Quality: ISO, CE Certified
Products: Blades, Drills, Saws (FDA Code: HSO), Pneumatic Neurosurgical Drill Systems, Handpieces, Large Bone Battery Power System, ...
Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sel more...
www.brasselerusamedical.com | Send Inquiry | Phone: +1-(800)-535-6638
FDA Registration: 2025102 Year Established: 1987 Employee Count: ~150 Quality: ISO, CE Certified
Products: Blades, Drills, Saws (FDA Code: HSO), Pneumatic Neurosurgical Drill Systems, Handpieces, Large Bone Battery Power System, ...
Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sel 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...
Stoelting Co. | Address: 620 Wheat Lane, Wood Dale, Illinois 60191, USA
www.stoeltingco.com | Send Inquiry | Phone: +1-(630)-860-9700, 800-860-9775
Products: In Vitro Fertilization Equipment & Supplies, Sutures, Fixation Forceps, Tissue Forceps, Bone Rongeurs, Self-Retaining Retractors (FDA Code: FFO), ...
Stoelting Co. produces and distributes instruments for basic biomedical research in neuroscience & physiology. Our ANY-maze™ is a flexible video tracking system designed to automate testing in b more...
www.stoeltingco.com | Send Inquiry | Phone: +1-(630)-860-9700, 800-860-9775
Products: In Vitro Fertilization Equipment & Supplies, Sutures, Fixation Forceps, Tissue Forceps, Bone Rongeurs, Self-Retaining Retractors (FDA Code: FFO), ...
Stoelting Co. produces and distributes instruments for basic biomedical research in neuroscience & physiology. Our ANY-maze™ is a flexible video tracking system designed to automate testing in b more...
Roboz Surgical Instrument Co., Inc. | Address: P.O. Box 10710, Gaithersburg, Maryland 20898-0710, USA
www.roboz.com | Send Inquiry | Phone: +1-(301)-590.0055
FDA Registration: 1180552 Year Established: 1953 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: CE Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Retractors, Saws (FDA Code: HSO), Scalpels, Dressing Forceps, Fixation Forceps, ...
Roboz Surgical Instrument Co., Inc. specializes in providing hand-crafted surgical instruments. Our surgical instruments include tweezers & forceps, bone instruments, surgical & vascular clips & clamp more...
www.roboz.com | Send Inquiry | Phone: +1-(301)-590.0055
FDA Registration: 1180552 Year Established: 1953 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: CE Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Retractors, Saws (FDA Code: HSO), Scalpels, Dressing Forceps, Fixation Forceps, ...
Roboz Surgical Instrument Co., Inc. specializes in providing hand-crafted surgical instruments. Our surgical instruments include tweezers & forceps, bone instruments, surgical & vascular clips & clamp 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...
Life Instrument Corporation | Address: 14 Wood Rd. Suite 002, Braintree, Massachusetts 02184, USA
www.lifeinstruments.com | Phone: +1-(781)-849-0109, 800-925-2995
FDA Registration: 1222188
Products: Curettes, Elevators, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Freer Periosteal Elevators, ...
Life Instrument Corporation serves neuro surgeons and orthopedic surgeons with surgical instruments. Our products include spinal instruments and orthopedic instruments. The spinal & orthopedic instrum more...
www.lifeinstruments.com | Phone: +1-(781)-849-0109, 800-925-2995
FDA Registration: 1222188
Products: Curettes, Elevators, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Freer Periosteal Elevators, ...
Life Instrument Corporation serves neuro surgeons and orthopedic surgeons with surgical instruments. Our products include spinal instruments and orthopedic instruments. The spinal & orthopedic instrum more...
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...
spectramedical.com | Send Inquiry | Phone: +1-(978)-657-0889
FDA Registration: 1224960 Year Established: 1995 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Silicone Tubing, Catheter Introducers (FDA Code: DYB), Tunnelers, Blood Gas Capillary Tubes, Bedpans & Urinals, Surgical Gloves, ...
Spectra Medical Devices, Inc. is an OEM manufacturer of Custom Tray Components and Instruments. We specialize in Custom OEM Needles, Surgical and Dental Disposable Instruments. We are an ISO 9001 cert more...
Plastic Hub Epidural Needles | Metal Hub Epidural Needles | surgical disposables
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...
PMT Corporation | Address: 1500 Park Road, Chanhassen, Minnesota 55317, USA
www.pmtcorp.com | Send Inquiry | Phone: +1-(952)-470-0866, 800-626-5463
FDA Registration: 2182979 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 13485, CE Certified
Products: Bipolar Forceps, Scalp Hooks, Clips and Appliers, Dissectors, Micro Curettes, Gastroenterologic Needle Holder (FDA Code: FHQ), Rongeurs, ...
PMT Corporation manufactures products for neurosurgery, orthopaedics, plastic, and reconstructive surgery. We are accredited with ISO 13485: 2003 certification. All our products are FDA approved. Our more...
www.pmtcorp.com | Send Inquiry | Phone: +1-(952)-470-0866, 800-626-5463
FDA Registration: 2182979 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 13485, CE Certified
Products: Bipolar Forceps, Scalp Hooks, Clips and Appliers, Dissectors, Micro Curettes, Gastroenterologic Needle Holder (FDA Code: FHQ), Rongeurs, ...
PMT Corporation manufactures products for neurosurgery, orthopaedics, plastic, and reconstructive surgery. We are accredited with ISO 13485: 2003 certification. All our products are FDA approved. Our more...
Mccoy Health Science Supply | Address: 11559 Rock Island Court, Maryland Heights, Missouri 63043, USA
www.mccoymedical.com | Send Inquiry | Phone: +1-(314)-432-1400, 800-633-2665
FDA Registration: 3009668073
Products: Otoscopes, Stethoscopes, Ophthalmoscopes, Blades, Laryngoscopes, Watchmaker Forceps, ...
Mccoy Health Science Supply distributes medical equipment and accessories. We focus on strthoscope parts, penlights, charts, protective wear, scissors, dissection, diagnostic equipment, tuning forks, more...
www.mccoymedical.com | Send Inquiry | Phone: +1-(314)-432-1400, 800-633-2665
FDA Registration: 3009668073
Products: Otoscopes, Stethoscopes, Ophthalmoscopes, Blades, Laryngoscopes, Watchmaker Forceps, ...
Mccoy Health Science Supply distributes medical equipment and accessories. We focus on strthoscope parts, penlights, charts, protective wear, scissors, dissection, diagnostic equipment, tuning forks, 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...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Anesthesia Equipment, Hypodermic Syringes, Bodyfat Analyzers, Medical Thermometers, Blades, Scalpels, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Anesthesia Equipment, Hypodermic Syringes, Bodyfat Analyzers, Medical Thermometers, Blades, Scalpels, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
Sponsored Links
FDA Code / Regulation: GDZ / 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.
