Diagnostic/Surgical Loupe Suppliers
Limit companies to: Worldwide USA
Kerr Corporation | Address: 1717 West Collins., Orange, California 92867, USA 
www.kerrdental.com | Send Inquiry | Phone: +1-(714)-516-7400, 800-537-7123
FDA Registration: 2024312
Products: General Medical Supplies, Adhesive Bandages (FDA Code: KGX), Elastic Adhesive Bandages, Non-Adhesive Bandages, Flexible Fabric Adhesive Bandages, Adhesive Bandage Strip, ...
Kerr Corporation is a manufacturer of premiere dental consumables. Our broad range of consumable dental products includes alloys, bonding agents, bone grafting, cements, gingival retraction and impres more...
www.kerrdental.com | Send Inquiry | Phone: +1-(714)-516-7400, 800-537-7123
FDA Registration: 2024312
Products: General Medical Supplies, Adhesive Bandages (FDA Code: KGX), Elastic Adhesive Bandages, Non-Adhesive Bandages, Flexible Fabric Adhesive Bandages, Adhesive Bandage Strip, ...
Kerr Corporation is a manufacturer of premiere dental consumables. Our broad range of consumable dental products includes alloys, bonding agents, bone grafting, cements, gingival retraction and impres more...
Eschenbach Optik of America Inc. | Address: 904 Ethan Allen Highway, Ridgefield, Connecticut 06877, USA
www.eschenbach.com | Send Inquiry | Phone: +1-(905)-568-9977
FDA Registration: 3008309602 Quality: ISO 9001 Certified
Products: Hand-held Magnifiers, Non Illuminated Stand Magnifiers, Fixed Stand Magnifiers, Low Vision Aids, Video Magnification Systems, Head Borne Magnifiers, Non-Optical Products, ...
Eschenbach Optik of America Inc. offers optical & other magnification products. Our products include stand magnifiers, spectacle magnifiers, telescopes, absorptive filters, hand-held magnifiers, absor more...
www.eschenbach.com | Send Inquiry | Phone: +1-(905)-568-9977
FDA Registration: 3008309602 Quality: ISO 9001 Certified
Products: Hand-held Magnifiers, Non Illuminated Stand Magnifiers, Fixed Stand Magnifiers, Low Vision Aids, Video Magnification Systems, Head Borne Magnifiers, Non-Optical Products, ...
Eschenbach Optik of America Inc. offers optical & other magnification products. Our products include stand magnifiers, spectacle magnifiers, telescopes, absorptive filters, hand-held magnifiers, absor 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...
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...
FCI Ophthalmics | Address: P.O. Box 465, Marshfield Hills, Massachusetts 02051, USA
www.fci-ophthalmics.com | Send Inquiry | Phone: +1-(781)-826-9060
FDA Registration: 1225124 Year Established: 1996 Annual Revenues: USD 1-5 Million Quality: ISO 9002, CE Certified
Products: Conformers, Gold Weighted Eyelid Implants, Punctum Plugs (Punctal Plugs), Wright Needles, Evisceration Scoops, Titanium Plating Systems, ...
FCI Ophthalmics concentrates in ophthalmic surgical devices. Our products include retina, cataract, lid repair, orbital implants, lacrimal stents & tubes, and dry products. The orbital implant product more...
www.fci-ophthalmics.com | Send Inquiry | Phone: +1-(781)-826-9060
FDA Registration: 1225124 Year Established: 1996 Annual Revenues: USD 1-5 Million Quality: ISO 9002, CE Certified
Products: Conformers, Gold Weighted Eyelid Implants, Punctum Plugs (Punctal Plugs), Wright Needles, Evisceration Scoops, Titanium Plating Systems, ...
FCI Ophthalmics concentrates in ophthalmic surgical devices. Our products include retina, cataract, lid repair, orbital implants, lacrimal stents & tubes, and dry products. The orbital implant product 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...
General Scientific Corporation | Address: 77 Enterprise Drive, Ann Arbor, Michigan 48103, USA
www.surgitel.com | Send Inquiry | Phone: +1-(734)-996-9200
FDA Registration: 1834177 Year Established: 1990 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO, CE Certified
Products: Light Sources, Surgical Headlights, Dental Chairs, Image Enhancement Filters, Polarizing Filters, Telescope, ...
General Scientific Corporation offers telescopes, headlights, optical accessories, medical specialty, and dental specialty. Our optical accessories include laser filters, X-ray protection glasses, pol more...
www.surgitel.com | Send Inquiry | Phone: +1-(734)-996-9200
FDA Registration: 1834177 Year Established: 1990 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO, CE Certified
Products: Light Sources, Surgical Headlights, Dental Chairs, Image Enhancement Filters, Polarizing Filters, Telescope, ...
General Scientific Corporation offers telescopes, headlights, optical accessories, medical specialty, and dental specialty. Our optical accessories include laser filters, X-ray protection glasses, pol 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...
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...
Heine USA Ltd. | Address: 10 Innovation Way, Dover, New Hampshire 03820, USA
www.heine.com | Send Inquiry | Phone: +1-(603)-742-7103
FDA Registration: 1000379039 Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Otoscopes, Stethoscopes, Forceps (FDA Code: HTD), Direct Ophthalmoscopes, Loupes, Muscle Lights, ...
Heine USA Ltd. designs and manufactures diagnostic instruments. Our product includes otoscopes, ENT specialty instruments, pocket diagnostic lights, retinoscopes, hand-held slit lamps, binocular loupe more...
www.heine.com | Send Inquiry | Phone: +1-(603)-742-7103
FDA Registration: 1000379039 Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Otoscopes, Stethoscopes, Forceps (FDA Code: HTD), Direct Ophthalmoscopes, Loupes, Muscle Lights, ...
Heine USA Ltd. designs and manufactures diagnostic instruments. Our product includes otoscopes, ENT specialty instruments, pocket diagnostic lights, retinoscopes, hand-held slit lamps, binocular loupe more...
Carl Zeiss, Inc. | Address: One Zeiss Drive, Thornwood, New York 10594, USA
www.zeiss.com | Send Inquiry | Phone: +1-(914)-747-1800
FDA Registration: 2431026 Employee Count: ~240
Products: Fluorescent Microscopes, Digital Microscopy Cameras, Fluorescence Microscope Aids, Fluorescence Stereomicroscopes, Inverted Microscopes, Inverted Microscope Objectives, ...
Carl Zeiss, Inc. delivers microscopes, cameras & software, which are fully compatible and integrated into high-performance imaging systems. With Mirax scan, we launched a fully automated system soluti more...
www.zeiss.com | Send Inquiry | Phone: +1-(914)-747-1800
FDA Registration: 2431026 Employee Count: ~240
Products: Fluorescent Microscopes, Digital Microscopy Cameras, Fluorescence Microscope Aids, Fluorescence Stereomicroscopes, Inverted Microscopes, Inverted Microscope Objectives, ...
Carl Zeiss, Inc. delivers microscopes, cameras & software, which are fully compatible and integrated into high-performance imaging systems. With Mirax scan, we launched a fully automated system soluti more...
Keeler Instruments Inc. | Address: 456 Parkway, Broomall, Pennsylvania 19008, USA
www.keelerusa.com | Send Inquiry | Phone: +1-(610)-353-4350
FDA Registration: 2519784 Year Established: 1917 Employee Count: ~20 Quality: CE Certified
Products: Ophthalmic Loupes, Retinoscopes, Indocyanine Green Angiography, Fluorescein Angiography, Direct Ophthalmoscopes, Trial Lenses, ...
Keeler Instruments Inc. manufactures ophthalmic instruments. Our ophthalmic product includes binocular indirect ophthalmoscopes, cryo systems, handhelds, surgical loupes, lights, tonometers, bulbs, an more...
www.keelerusa.com | Send Inquiry | Phone: +1-(610)-353-4350
FDA Registration: 2519784 Year Established: 1917 Employee Count: ~20 Quality: CE Certified
Products: Ophthalmic Loupes, Retinoscopes, Indocyanine Green Angiography, Fluorescein Angiography, Direct Ophthalmoscopes, Trial Lenses, ...
Keeler Instruments Inc. manufactures ophthalmic instruments. Our ophthalmic product includes binocular indirect ophthalmoscopes, cryo systems, handhelds, surgical loupes, lights, tonometers, bulbs, an more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Schultz | Address: 514 White Ave, Henderson, Tennessee 38340, USA
https://www.loupedirect.com | Send Inquiry | Phone: +1-(855)-598-2020
Products: Eye Loupes, Acrylic Loupe, Folding Double Lens Pocket Loupe, Binocular Magnifying Loupe, Diagnostic/Surgical Loupe (FDA Code: FSP), Flip-Up Loupes, ...
Schultz offers surgical loupes. We also offer dental loupes and dental head lights. Surgical headlights are manufactured with varied quality of light. The factors include the spot size, intensity of l more...
https://www.loupedirect.com | Send Inquiry | Phone: +1-(855)-598-2020
Products: Eye Loupes, Acrylic Loupe, Folding Double Lens Pocket Loupe, Binocular Magnifying Loupe, Diagnostic/Surgical Loupe (FDA Code: FSP), Flip-Up Loupes, ...
Schultz offers surgical loupes. We also offer dental loupes and dental head lights. Surgical headlights are manufactured with varied quality of light. The factors include the spot size, intensity of l more...
Microsurgery Instruments, Inc. | Address: P.O. BOX 1378, Bellaire, Texas 77402, USA
www.microsurgeryusa.com | Send Inquiry | Phone: +1-(713)-664-4707
FDA Registration: 1645452
Products: Surgical Loupes, Light Sources Advanced Light Source, Light Sources White Light Source, Light Sources Creative Light Source, Light Sources Alternative Light Source, Surgical Lighting, ...
Microsurgery Instruments, Inc. specializes in microsurgery and other delicate surgical products. We focus on orthopedics, cardiovascular, plastic surgery, hand surgery, urology, surgical loupes, needl more...
www.microsurgeryusa.com | Send Inquiry | Phone: +1-(713)-664-4707
FDA Registration: 1645452
Products: Surgical Loupes, Light Sources Advanced Light Source, Light Sources White Light Source, Light Sources Creative Light Source, Light Sources Alternative Light Source, Surgical Lighting, ...
Microsurgery Instruments, Inc. specializes in microsurgery and other delicate surgical products. We focus on orthopedics, cardiovascular, plastic surgery, hand surgery, urology, surgical loupes, needl more...
PeriOptix, Inc. | Address: 230 North Market Place, Escondido, California 92029, USA
www.perioptix.com | Phone: +1-(949)-366-3333, 888-360-0033
Products: Surgical Loupes, Portable Headlight, Diagnostic/Surgical Loupe (FDA Code: FSP), Battery-Powered Medical Examination Light (FDA Code: KYT), Low Power Binocular Loupe (FDA Code: HJH), Ophthalmic Eye Shield (FDA Code: HOY), ...
PeriOptix, Inc. is associated with optics and illumination. We deal with loupes and portable LED headlights. Our Solaris™ portable dental and surgical LED light source uses LED technology. It we more...
www.perioptix.com | Phone: +1-(949)-366-3333, 888-360-0033
Products: Surgical Loupes, Portable Headlight, Diagnostic/Surgical Loupe (FDA Code: FSP), Battery-Powered Medical Examination Light (FDA Code: KYT), Low Power Binocular Loupe (FDA Code: HJH), Ophthalmic Eye Shield (FDA Code: HOY), ...
PeriOptix, Inc. is associated with optics and illumination. We deal with loupes and portable LED headlights. Our Solaris™ portable dental and surgical LED light source uses LED technology. It we more...
Insight Instruments, Inc. | Address: 2580 S.E. Willoughby Blvd., Stuart, Florida 34994, USA
www.insightinstruments.com | Phone: +1-(772)-219-9393, 800-255-8354
FDA Registration: 1052234 Annual Revenues: USD 1-5 Million
Products: Disposable Ophthalmic Cannulae, Diagnostic/Surgical Loupe (FDA Code: FSP), Battery-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HKP), Corneo-Scleral Punch (FDA Code: HNJ), Diagnostic Condensing Lens (FDA Code: HJL), Diagnostic Polymethylmethacrylate Contact Lens (FDA Code: HJK), ...
Insight Instruments, Inc. specializes in production, development and sale of instruments to vitreo retinal surgeons. Our BIOM 3 incorporates the principle of indirect opthalmoscopy in the operating mi more...
www.insightinstruments.com | Phone: +1-(772)-219-9393, 800-255-8354
FDA Registration: 1052234 Annual Revenues: USD 1-5 Million
Products: Disposable Ophthalmic Cannulae, Diagnostic/Surgical Loupe (FDA Code: FSP), Battery-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HKP), Corneo-Scleral Punch (FDA Code: HNJ), Diagnostic Condensing Lens (FDA Code: HJL), Diagnostic Polymethylmethacrylate Contact Lens (FDA Code: HJK), ...
Insight Instruments, Inc. specializes in production, development and sale of instruments to vitreo retinal surgeons. Our BIOM 3 incorporates the principle of indirect opthalmoscopy in the operating mi more...
Five Star Surgical, Inc. | Address: 163 Barnet Boulevard, New Bedford, Massachusetts 02745, USA
surgical.fivestarcompanies.net | Send Inquiry | Phone: +1-(508)-998-1404, 877-595-7827
FDA Registration: 3004513872 Year Established: 1998
Products: Clamps, Curettes, Retractors, Scissors, Bipolar Forceps, Diagnostic/Surgical Loupe (FDA Code: FSP), ...
Five Star Surgical, Inc. manufactures and repairs surgical instruments. We distribute laparoscopic instruments and sterilization containers. Our product line includes scissors, ronguers, curettes, ret more...
surgical.fivestarcompanies.net | Send Inquiry | Phone: +1-(508)-998-1404, 877-595-7827
FDA Registration: 3004513872 Year Established: 1998
Products: Clamps, Curettes, Retractors, Scissors, Bipolar Forceps, Diagnostic/Surgical Loupe (FDA Code: FSP), ...
Five Star Surgical, Inc. manufactures and repairs surgical instruments. We distribute laparoscopic instruments and sterilization containers. Our product line includes scissors, ronguers, curettes, ret more...
Roldan Products Corp. | Address: 448 Sovereign Court, Ballwin, Missouri 63021, USA
www.roldanexport.com | Send Inquiry | Phone: +1-(636)-527-6800, 866-922-6800
Year Established: 1926 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Diagnostic/Surgical Loupe (FDA Code: FSP), Viewer/Magnifier, Examination (Light) Lamp, Overbed Light, Non Heating Infrared Lamp (FDA Code: IOB), High Intensity Light, ...
Roldan Products Corp. offers electrical lamps which are used in the medical field. more...
www.roldanexport.com | Send Inquiry | Phone: +1-(636)-527-6800, 866-922-6800
Year Established: 1926 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Diagnostic/Surgical Loupe (FDA Code: FSP), Viewer/Magnifier, Examination (Light) Lamp, Overbed Light, Non Heating Infrared Lamp (FDA Code: IOB), High Intensity Light, ...
Roldan Products Corp. offers electrical lamps which are used in the medical field. more...
Koehler Instrument Co., Inc. | Address: 1595 Sycamore Avenue, Bohemia, New York 11716, USA
www.koehlerinstrument.com | Send Inquiry | Phone: +1-(631)-589-3800, 800-878-9070
FDA Registration: 2431764 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Colorimeter, Clinical Colorimeter (FDA Code: JJQ), Diagnostic/Surgical Loupe (FDA Code: FSP), Fiberoptic Surgical Light (FDA Code: FST), General & Plastic Surgery Surgical Microscope (FDA Code: FSO), Battery-Operated Operating Headlamp (FDA Code: HPP), ...
Koehler Instrument Co., Inc. offers penetrometers and colorimeters. Our K13550 colorimeter has features such as touch-screen TFT-color display, automatic cuvette recognition, and automatic zero calibr more...
www.koehlerinstrument.com | Send Inquiry | Phone: +1-(631)-589-3800, 800-878-9070
FDA Registration: 2431764 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Colorimeter, Clinical Colorimeter (FDA Code: JJQ), Diagnostic/Surgical Loupe (FDA Code: FSP), Fiberoptic Surgical Light (FDA Code: FST), General & Plastic Surgery Surgical Microscope (FDA Code: FSO), Battery-Operated Operating Headlamp (FDA Code: HPP), ...
Koehler Instrument Co., Inc. offers penetrometers and colorimeters. Our K13550 colorimeter has features such as touch-screen TFT-color display, automatic cuvette recognition, and automatic zero calibr more...
Sponsored Links
FDA Code / Regulation: FSP / 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.
