Manual Saw & Accessories Suppliers
Limit companies to: Worldwide USA
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA 
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
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...
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...
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...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni 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...
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...
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: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
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: Forceps (FDA Code: HTD), Scissors, Vasectomy Ringed Forceps, Vasectomy Hemostats, General Medical Supplies, General Surgical Instruments, ...
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...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Ankle Distractors, General Surgical Instruments, Packaging, Spinal Implants, Medical Diagnostic Imaging, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Ankle Distractors, General Surgical Instruments, Packaging, Spinal Implants, Medical Diagnostic Imaging, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Medos S.A. | Address: Rue Girardet 29, Le Locle CH 2400, Switzerland
Phone: +41-(56)-703 333
FDA Registration: 8031062
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Burr Hole Cover (FDA Code: GXR), Shunt System Implantation Instrument (FDA Code: GYK), Central Nervous System and Components (FDA Code: JXG), ...
Medos S.A. specializes in diagnostic and therapeutic products. We provide instruments for shunt system implantation, central nervous system shunts & valves and burr hole covers. more...
Phone: +41-(56)-703 333
FDA Registration: 8031062
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Burr Hole Cover (FDA Code: GXR), Shunt System Implantation Instrument (FDA Code: GYK), Central Nervous System and Components (FDA Code: JXG), ...
Medos S.A. specializes in diagnostic and therapeutic products. We provide instruments for shunt system implantation, central nervous system shunts & valves and burr hole covers. more...
Accuray Surgicals Ltd. | Address: Lakson Square Bldg. #2, Sarwar Shaheed Rd., Karachi 74200, Pakistan
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, Tuning Forks (FDA Code: GWX), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, Tuning Forks (FDA Code: GWX), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
M.F. Elahi & Co. (EP) Pvt. Ltd. | Address: # 309.102.30 Wazirabad Road, Kotli Behram, Sialkot 22161, Pakistan
Phone: +92-(432)-55467
Products: Forceps Needle Holders, Hexagonal Needle Holder, Surgical Retractor Systems (FDA Code: GAD), Micro Ophthalmic Scissors, Ophthalmic Suture Scissors (FDA Code: HNF), Surgical Retractor (FDA Code: GAD), ...
M.F. Elahi & Co. (EP) Pvt. Ltd. provides ophthalmic scissors, surgical scissors, wire cutter, forceps & retractors. We also offer needle and scalpel handles. more...
Phone: +92-(432)-55467
Products: Forceps Needle Holders, Hexagonal Needle Holder, Surgical Retractor Systems (FDA Code: GAD), Micro Ophthalmic Scissors, Ophthalmic Suture Scissors (FDA Code: HNF), Surgical Retractor (FDA Code: GAD), ...
M.F. Elahi & Co. (EP) Pvt. Ltd. provides ophthalmic scissors, surgical scissors, wire cutter, forceps & retractors. We also offer needle and scalpel handles. more...
QSA Surgical (Pvt) Ltd. | Address: Ghuinke Daska Road .P.O.Box 1094, Sialkot 051310, Pakistan
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Uterine Packer (FDA Code: HDM), Hemostats (FDA Code: HRQ), Sterile ENT Wire Cutting Scissors (FDA Code: JYA), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Uterine Packer (FDA Code: HDM), Hemostats (FDA Code: HRQ), Sterile ENT Wire Cutting Scissors (FDA Code: JYA), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
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FDA Code / Regulation: GDR / 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.
