Surgical Retractor Systems Suppliers
Limit companies to: Worldwide USA
Gyrus ACMI | Address: 136 Turnpike Road, Southborough, Massachusetts 01772-2104, USA 
medical.olympusamerica.com | Send Inquiry | Phone: +1-(508)-804.2600
FDA Registration: 1519132 Year Established: 1900 Annual Revenues: USD 50-100 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Laryngoscopes, Light Sources, Cameras, Fluid Management Systems, ...
Gyrus ACMI is engaged in medical device business. We offer urology, gynecology, ENT and anesthesiology products. Our urology products include cystourethroscopes, cystonephroscopes, laparoscopy, percut more...
medical.olympusamerica.com | Send Inquiry | Phone: +1-(508)-804.2600
FDA Registration: 1519132 Year Established: 1900 Annual Revenues: USD 50-100 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Laryngoscopes, Light Sources, Cameras, Fluid Management Systems, ...
Gyrus ACMI is engaged in medical device business. We offer urology, gynecology, ENT and anesthesiology products. Our urology products include cystourethroscopes, cystonephroscopes, laparoscopy, percut 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...
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: Vaginal Retractors (FDA Code: HDL), Anterior, Surgical Retractor Systems (FDA Code: GAD), Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, ...
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: Vaginal Retractors (FDA Code: HDL), Anterior, Surgical Retractor Systems (FDA Code: GAD), Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, ...
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...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Insufflators, Saws (FDA Code: HSO), Light Sources, Bipolar Forceps, Titanium Plating Systems, Bone Drills, ...
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: Insufflators, Saws (FDA Code: HSO), Light Sources, Bipolar Forceps, Titanium Plating Systems, Bone Drills, ...
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 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...
Scanlan International | Address: One Scanlan Plaza, St. Paul, Minnesota 55107, USA
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scissors, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scissors, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
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), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Posterior Cervical Plating Systems, Surgical Retractor Systems (FDA Code: GAD), Anterior Cruciate Ligament Surgical Reconstruction System, ...
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), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Posterior Cervical Plating Systems, Surgical Retractor Systems (FDA Code: GAD), Anterior Cruciate Ligament Surgical Reconstruction System, ...
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...
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: Vaginal Retractors (FDA Code: HDL), Retractors, Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Swabs, Fan 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: Vaginal Retractors (FDA Code: HDL), Retractors, Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Swabs, Fan 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...
Kmedic | Address: 190 Veterans Drive, Northvale, New Jersey 07647, USA
www.kmedic.com | Send Inquiry | Phone: +1-(201)-767-4002
FDA Registration: 3012164475 Year Established: 1986 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Curettes, Forceps (FDA Code: HTD), Mallets, Retractors, Saws (FDA Code: HSO), Scissors, ...
Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products l more...
www.kmedic.com | Send Inquiry | Phone: +1-(201)-767-4002
FDA Registration: 3012164475 Year Established: 1986 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Curettes, Forceps (FDA Code: HTD), Mallets, Retractors, Saws (FDA Code: HSO), Scissors, ...
Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products l more...
Integra LifeSciences Corporation | Address: 311 Enterprise Drive, Plainsboro, New Jersey 08536, USA
www.integra-ls.com | Send Inquiry | Phone: +1-(609)-275-0500
FDA Registration: 3003418325 Year Established: 1989 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~2500 Quality: CE Certified
Products: Elevators, Retractors, Scissors, Disposables, Dermatomes, Bipolar Forceps, ...
Integra LifeSciences Corporation develops & markets surgical instruments, as well as devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Our S more...
www.integra-ls.com | Send Inquiry | Phone: +1-(609)-275-0500
FDA Registration: 3003418325 Year Established: 1989 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~2500 Quality: CE Certified
Products: Elevators, Retractors, Scissors, Disposables, Dermatomes, Bipolar Forceps, ...
Integra LifeSciences Corporation develops & markets surgical instruments, as well as devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Our S more...
Ethicon, Inc. | Address: P.O. Box 151,Route 22 West, Somerville, New Jersey 08876, USA
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
Conmed Corporation | Address: 525 French Road, Utica, New York 13502, USA
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: Audiometers & Tympanometers, Otoscopes, Forceps (FDA Code: HTD), Scissors, Bipolar Cautery Systems, Monopolar Cautery Systems, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: Audiometers & Tympanometers, Otoscopes, Forceps (FDA Code: HTD), Scissors, Bipolar Cautery Systems, Monopolar Cautery Systems, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Applied Medical Technology, Inc. | Address: 15653 Neo Parkway, Cleveland, Ohio 44128, USA
www.appliedmedical.net | Send Inquiry | Phone: +1-(216)-475-5577, (800)-869-7382
FDA Registration: 1526012 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, General Medical Supplies, Surgical Retractor Systems (FDA Code: GAD), Smoke & Fluid Tube Evacuator, ...
Applied Medical Technology, Inc. develops and assembles medical devices. We offer innovative & reliable products for use in the medical and surgical environment, with a special emphasis on gastrostomy more...
www.appliedmedical.net | Send Inquiry | Phone: +1-(216)-475-5577, (800)-869-7382
FDA Registration: 1526012 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, General Medical Supplies, Surgical Retractor Systems (FDA Code: GAD), Smoke & Fluid Tube Evacuator, ...
Applied Medical Technology, Inc. develops and assembles medical devices. We offer innovative & reliable products for use in the medical and surgical environment, with a special emphasis on gastrostomy more...
Cardinal Health, Inc. | Address: 7000 Cardinal Place, Dublin, Ohio 43017, USA
www.cardinal.com | Phone: +1-(614)-757-5000, 800-234-8701
Products: Cameras, Video & Optical Systems, Heat or Cold Packs, Disposables, Light Sources, Endoscopes, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipmen more...
www.cardinal.com | Phone: +1-(614)-757-5000, 800-234-8701
Products: Cameras, Video & Optical Systems, Heat or Cold Packs, Disposables, Light Sources, Endoscopes, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cardinal Health is a manufacturer and distributor of medical & surgical supplies. Our clinical and medical products segment manufactures medication infusion & dispensing products, respiratory equipmen more...
Conmed Integrated Systems | Address: 1815 NW 169th Place, Suite 4020, Beaverton, Oregon 97006, USA
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
Almore International Inc. | Address: P.O. Box 25214, Portland, Oregon 97298, USA
www.almore.com | Send Inquiry | Phone: +1-(503)-643-6633, 800-547-1511
FDA Registration: 3018986 Year Established: 1946 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Obstetrical Retractors, Retractors, Desmarres Lid Retractors, Rake Retractors, Jaffe Lid Retractors, Army-Navy Retractors, ...
Almore International Inc deal with dental products. Our product categories are endodontics, eyewear, infection control, lab supplies, and operatory. Out Tongue-B-Gone is designed to maintain suction w more...
www.almore.com | Send Inquiry | Phone: +1-(503)-643-6633, 800-547-1511
FDA Registration: 3018986 Year Established: 1946 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Obstetrical Retractors, Retractors, Desmarres Lid Retractors, Rake Retractors, Jaffe Lid Retractors, Army-Navy Retractors, ...
Almore International Inc deal with dental products. Our product categories are endodontics, eyewear, infection control, lab supplies, and operatory. Out Tongue-B-Gone is designed to maintain suction w 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: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Stethoscopes, Pelvimeters, Vaginal Retractors (FDA Code: HDL), Tonometers, Autoclaves, Curettes, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Stethoscopes, Pelvimeters, Vaginal Retractors (FDA Code: HDL), Tonometers, Autoclaves, Curettes, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
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FDA Code / Regulation: GAD / 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.
