General Surgical Manual Instrument Suppliers
Limit companies to: Worldwide USA
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: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
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: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
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: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
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: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
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...
Paragon Medical, Inc. | Address: 8 Matchett Industrial Park Drive, Pierceton, Indiana 46562, USA
www.paragonmedical.com | Send Inquiry | Phone: +1-(574)-594-2140, 800-225-6975
FDA Registration: 1834331 Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~600 Quality: ISO 9001 Certified
Products: Procedure Trays, General Medical Supplies, Medical Procedure Trays, Operating Procedure Trays, Procedure TrayS For Surgery, Sterile Procedure Trays, ...
Paragon Medical, Inc. provides solutions for cases & trays, surgical instrumentation, and implantable components. ChromaSim is our tool for exploring our color options for cases & trays and surgical i more...
www.paragonmedical.com | Send Inquiry | Phone: +1-(574)-594-2140, 800-225-6975
FDA Registration: 1834331 Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~600 Quality: ISO 9001 Certified
Products: Procedure Trays, General Medical Supplies, Medical Procedure Trays, Operating Procedure Trays, Procedure TrayS For Surgery, Sterile Procedure Trays, ...
Paragon Medical, Inc. provides solutions for cases & trays, surgical instrumentation, and implantable components. ChromaSim is our tool for exploring our color options for cases & trays and surgical i more...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
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: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
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: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
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: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
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: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
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: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
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...
Hologic Inc | Address: 35 Crosby Drive, Bedford, Massachusetts 01730, USA
www.hologic.com | Send Inquiry | Phone: +1-(781)-999-7300
FDA Registration: 1220984 Year Established: 1985
Products: Contract Manufacturers, Needles, Fluoroscopy Systems, Fluoroscopic Imaging Systems, Portable Fluoroscopes, Digital Mammography Systems, ...
Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiogr more...
www.hologic.com | Send Inquiry | Phone: +1-(781)-999-7300
FDA Registration: 1220984 Year Established: 1985
Products: Contract Manufacturers, Needles, Fluoroscopy Systems, Fluoroscopic Imaging Systems, Portable Fluoroscopes, Digital Mammography Systems, ...
Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiogr more...
Solos Endoscopy,Inc. | Address: 65 Sprague Street, Boston, Massachusetts 02136, USA
www.solosendoscopy.com | Send Inquiry | Phone: +1-(617)-360-9700
Products: Scissors, Light Sources, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Cameras, Recording Devices, ...
Solos Endoscopy develops advanced surgical instruments and diagnostic solutions. We offer products like tympanoplasty & stapes, endoscopic sinus surgery & septorhinoplasty. Our monitors and video cart more...
www.solosendoscopy.com | Send Inquiry | Phone: +1-(617)-360-9700
Products: Scissors, Light Sources, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Cameras, Recording Devices, ...
Solos Endoscopy develops advanced surgical instruments and diagnostic solutions. We offer products like tympanoplasty & stapes, endoscopic sinus surgery & septorhinoplasty. Our monitors and video cart more...
Codman & Shurtleff, Inc. | Address: 325 Paramount Dr., Raynham, Massachusetts 02767, USA
www.codman.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1226348 Year Established: 1857 Annual Revenues: < USD 1 Million Employee Count: ~1200 Quality: ISO 9000 Certified
Products: Anterior Cervical Fusion Kit, Cervical Drill Tips, Cervical Drill Guards, Cross Bar Handle, Depth Gauge (FDA Code: HTJ), Spanner Gauge, ...
Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pedi more...
www.codman.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1226348 Year Established: 1857 Annual Revenues: < USD 1 Million Employee Count: ~1200 Quality: ISO 9000 Certified
Products: Anterior Cervical Fusion Kit, Cervical Drill Tips, Cervical Drill Guards, Cross Bar Handle, Depth Gauge (FDA Code: HTJ), Spanner Gauge, ...
Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pedi 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: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
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: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
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...
Thompson Surgical Instruments, Inc. | Address: 10170 E Cherry Bend Rd, Traverse City, Massachusetts 49684, USA
www.thompsonsurgical.com | Send Inquiry | Phone: +1-(231)-922-0177,800-227-7543
FDA Registration: 1450428 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, Flexible Scope Holder, Laparoscopic Retractor, ...
Thompson Surgical Instruments, Inc. produces a mechanical retractor which offers one frame for all exposure needs, multi-planed retraction and unlimited customization. Our anterior cervical access kit more...
www.thompsonsurgical.com | Send Inquiry | Phone: +1-(231)-922-0177,800-227-7543
FDA Registration: 1450428 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, Flexible Scope Holder, Laparoscopic Retractor, ...
Thompson Surgical Instruments, Inc. produces a mechanical retractor which offers one frame for all exposure needs, multi-planed retraction and unlimited customization. Our anterior cervical access kit 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: Bedpans & Urinals, Adult Bedpans, Brachytherapy, Implant Needles, Bone Marrow Biopsy Needle, Bone Surgery Surgical Instrument, Aluminum Hub Spinal Introducer Needles, ...
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: Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Vascular Clamps (FDA Code: DXC), Metal Skull Clamps, ...
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: Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Vascular Clamps (FDA Code: DXC), Metal Skull Clamps, ...
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...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we 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 Electrode Cables, Adapters & Connectors, Neonatal Temperature Probe Adapter, Back Orthoses, Adult Skin Temperature Probes, Adult Rectal Temperature Probes, Battery-Operated Operating Headlamp (FDA Code: HPP), ...
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 Electrode Cables, Adapters & Connectors, Neonatal Temperature Probe Adapter, Back Orthoses, Adult Skin Temperature Probes, Adult Rectal Temperature Probes, Battery-Operated Operating Headlamp (FDA Code: HPP), ...
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...
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, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
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, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
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...
Omni-tract Surgical | Address: 4849 White Bear Parkway, St. Paul, Minnesota 55110, USA
www.omni-tract.com | Send Inquiry | Phone: +1-(651)-287 4300, 800 367 8657
Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Self-Retaining Retractors (FDA Code: FFO), Posterior Cervical Plating Systems, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, posterior cruciate ligament Instruments, ...
Omni-tract Surgical designs, develops & produces ring retracators, wishbone retractors, speed-tract, fast systed, omni flex, specialty blades, and orthopedic retractors. Our Omni-Flex™ retractor more...
www.omni-tract.com | Send Inquiry | Phone: +1-(651)-287 4300, 800 367 8657
Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Self-Retaining Retractors (FDA Code: FFO), Posterior Cervical Plating Systems, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, posterior cruciate ligament Instruments, ...
Omni-tract Surgical designs, develops & produces ring retracators, wishbone retractors, speed-tract, fast systed, omni flex, specialty blades, and orthopedic retractors. Our Omni-Flex™ retractor 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: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
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: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
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...
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: Bone Taps (FDA Code: HWX), Bone Mill (FDA Code: LYS), Bender (FDA Code: HXW), Bone Cap (FDA Code: JDT), Bone Screw Starter (FDA Code: HWD), Compression Instrument (FDA Code: HWN), ...
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: Bone Taps (FDA Code: HWX), Bone Mill (FDA Code: LYS), Bender (FDA Code: HXW), Bone Cap (FDA Code: JDT), Bone Screw Starter (FDA Code: HWD), Compression Instrument (FDA Code: HWN), ...
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...
Automated Medical Products Corp. | Address: P.O. BOX 2508, Edison, New Jersey 08818, USA
www.ironintern.com | Send Inquiry | Phone: +1-(732)-602-7717, 800-832-4567
FDA Registration: 2431453 Year Established: 1977 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Retractors, Swabs, Fan Retractors, Gynecological Retractors, Eyelid Procedures, Army-Navy Retractors, Iris Hooks and Retractors, Binkhorst, Ophthalmology, Retractors, ...
Automated Medical Products Corp. manufactures and distributes specialized surgical equipments. Our principle product is the retractor holding device, Iron Intern ®. This device comes in a single a more...
www.ironintern.com | Send Inquiry | Phone: +1-(732)-602-7717, 800-832-4567
FDA Registration: 2431453 Year Established: 1977 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Retractors, Swabs, Fan Retractors, Gynecological Retractors, Eyelid Procedures, Army-Navy Retractors, Iris Hooks and Retractors, Binkhorst, Ophthalmology, Retractors, ...
Automated Medical Products Corp. manufactures and distributes specialized surgical equipments. Our principle product is the retractor holding device, Iron Intern ®. This device comes in a single 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.
