General & Plastic Surgery Surgical File 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...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
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...
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, Scissors, Bone Cutters, ...
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, Scissors, Bone Cutters, ...
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...
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: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
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: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
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...
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: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
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: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
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...
Wixom Engineering, LLC | Address: 30124 Via Arboleda, Temecula, California 92591, USA
Products: General & Plastic Surgery Surgical File (FDA Code: GEO), ...
Wixom Engineering, LLC specializes in offering general and plastic surgery surgical file. more...
Products: General & Plastic Surgery Surgical File (FDA Code: GEO), ...
Wixom Engineering, LLC specializes in offering general and plastic surgery surgical file. 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...
Unisplint Corp. | Address: 5139 Jimmy Carter Blvd, Norcross, Georgia 30093-1680, USA
Send Inquiry | Phone: +1-(770)-448-8549, 800-695-2553
Annual Revenues: < USD 1 Million
Products: Splints, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), General & Plastic Surgery Surgical File (FDA Code: GEO), Obstruction Removal Airway, Jaw Fracture Fixation Device, ...
Unisplint Corp. is a supplier of medical and hospital equipment. more...
Send Inquiry | Phone: +1-(770)-448-8549, 800-695-2553
Annual Revenues: < USD 1 Million
Products: Splints, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), General & Plastic Surgery Surgical File (FDA Code: GEO), Obstruction Removal Airway, Jaw Fracture Fixation Device, ...
Unisplint Corp. is a supplier of medical and hospital equipment. 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...
Symmetry Medical USA, Inc. | Address: 486 West 350 North, Warsaw, Indiana 46582, USA
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Blade Holders, Arthroscopy, Hook Knife, Arthroscopy, Meniscutome, Acetabular Cup System, Awl (FDA Code: HWJ), Curettes (FDA Code: HTF), ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Blade Holders, Arthroscopy, Hook Knife, Arthroscopy, Meniscutome, Acetabular Cup System, Awl (FDA Code: HWJ), Curettes (FDA Code: HTF), ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
Buxton Biomedical, Inc. | Address: 15a Melaine Lane, Unit 7, East Hanover, New Jersey 07936, USA
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Mallets, Retractors, Self-Retaining Retractors (FDA Code: FFO), Calipers, Goniometers, Cannulas, ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Mallets, Retractors, Self-Retaining Retractors (FDA Code: FFO), Calipers, Goniometers, Cannulas, ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Delta Surgical Instruments, Inc. | Address: 95 Schunnemunk Rd., Highland Mills, New York 10930, USA
www.deltasurgicalinstruments.com | Send Inquiry | Phone: +1-(845)-9283760
FDA Registration: 3005609209
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Depth Gauge (FDA Code: HTJ), Bender (FDA Code: HXW), Bone Trephine (FDA Code: HWK), Curettes (FDA Code: HTF), ...
Delta Surgical Instruments, Inc. manufactures dental surgical instruments. Our product line comprises of forceps, retractors, towel clamps, rasps, spinal punches, splinter forceps, sponge clamps, rong more...
www.deltasurgicalinstruments.com | Send Inquiry | Phone: +1-(845)-9283760
FDA Registration: 3005609209
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Depth Gauge (FDA Code: HTJ), Bender (FDA Code: HXW), Bone Trephine (FDA Code: HWK), Curettes (FDA Code: HTF), ...
Delta Surgical Instruments, Inc. manufactures dental surgical instruments. Our product line comprises of forceps, retractors, towel clamps, rasps, spinal punches, splinter forceps, sponge clamps, rong more...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
Reda Instrumente GmbH | Address: 30 Lorong Ampas #05-01 Skywaves 328783, Singapore
www.reda.com.sg | Send Inquiry | Phone: +65-(6858)-0506
FDA Registration: 8043496 Quality: DIN ISO 9001, DIN EN 46001 Certified
Products: Castroviejo Corneal Scissors, Mayo Scissors, Penetrating Keratoplasty, Castroviejo Corneal Scissors, Universal Castroviejo Corneal Scissors, Modified Castroviejo corneal scissors, Tungsten Carbide Blades Mayo Scissors, ...
Reda Instrumente GmbH supplies surgical instruments and surgical accessories to hospitals & operating rooms. Our wide range surgical instruments includes general, cardiovascular, thoracic, neurosurger more...
www.reda.com.sg | Send Inquiry | Phone: +65-(6858)-0506
FDA Registration: 8043496 Quality: DIN ISO 9001, DIN EN 46001 Certified
Products: Castroviejo Corneal Scissors, Mayo Scissors, Penetrating Keratoplasty, Castroviejo Corneal Scissors, Universal Castroviejo Corneal Scissors, Modified Castroviejo corneal scissors, Tungsten Carbide Blades Mayo Scissors, ...
Reda Instrumente GmbH supplies surgical instruments and surgical accessories to hospitals & operating rooms. Our wide range surgical instruments includes general, cardiovascular, thoracic, neurosurger more...
Chifa Sp. Z.o.o. | Address: Ul. Tysiaclecia, Nowy Tomysl, Poland
Phone: +48-(61)-4420100
FDA Registration: 9680260
Products: Forceps Needle Holders, Hexagonal Needle Holder, Surgical Retractor Systems (FDA Code: GAD), Ligature Carrier Set (FDA Code: GEJ), Ligature Carrier (FDA Code: GEJ), Surgical Retractor (FDA Code: GAD), ...
Chifa Sp. Z.o.o. specializes in offering surgical products. We offer ligature carriers, surgical clamps, dental scissors, crown scissors, dental elevators, ophthalmic forceps, needle holders, orthodon more...
Phone: +48-(61)-4420100
FDA Registration: 9680260
Products: Forceps Needle Holders, Hexagonal Needle Holder, Surgical Retractor Systems (FDA Code: GAD), Ligature Carrier Set (FDA Code: GEJ), Ligature Carrier (FDA Code: GEJ), Surgical Retractor (FDA Code: GAD), ...
Chifa Sp. Z.o.o. specializes in offering surgical products. We offer ligature carriers, surgical clamps, dental scissors, crown scissors, dental elevators, ophthalmic forceps, needle holders, orthodon 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.J. Instruments Company (Pvt) Ltd. | Address: Small Industries Estate, Sialkot 22161, Pakistan
Phone: +92-(432)-256627
FDA Registration: 8043752
Products: Oxygen Nasal Catheter (FDA Code: BZB), Disposable Medical Scissors (FDA Code: JOK), Manual Rongeur (FDA Code: HAE), Percussor, Vibrator (FDA Code: GWZ), Fixed Size Cervical Dilator (FDA Code: HDQ), Gynecological Biopsy Forceps (FDA Code: HFB), ...
M.J. Instruments Company (Pvt) Ltd. is a manufacturer of cutting forceps, biopsy forceps, rongeurs, and anoscopes. more...
Phone: +92-(432)-256627
FDA Registration: 8043752
Products: Oxygen Nasal Catheter (FDA Code: BZB), Disposable Medical Scissors (FDA Code: JOK), Manual Rongeur (FDA Code: HAE), Percussor, Vibrator (FDA Code: GWZ), Fixed Size Cervical Dilator (FDA Code: HDQ), Gynecological Biopsy Forceps (FDA Code: HFB), ...
M.J. Instruments Company (Pvt) Ltd. is a manufacturer of cutting forceps, biopsy forceps, rongeurs, and anoscopes. more...
Bukhsh International | Address: P.O.Box No 2313, Sialkot 51310, Pakistan
www.bukhsh.com | Send Inquiry | Phone: +92-(52)-4264335
FDA Registration: 3003454257
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Suture Forceps, Tonsil Snares (FDA Code: KBZ), Tonsil Forceps, Adenoid Curettes (FDA Code: KBJ), Trachea Dilating Forceps, ...
Bukhsh International offers surgical, dental, hair transplantation, and hollow ware products. We manufacture surgical instruments that are widely used in hospitals and surgery centers. We offer these more...
www.bukhsh.com | Send Inquiry | Phone: +92-(52)-4264335
FDA Registration: 3003454257
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Suture Forceps, Tonsil Snares (FDA Code: KBZ), Tonsil Forceps, Adenoid Curettes (FDA Code: KBJ), Trachea Dilating Forceps, ...
Bukhsh International offers surgical, dental, hair transplantation, and hollow ware products. We manufacture surgical instruments that are widely used in hospitals and surgery centers. We offer these more...
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FDA Code / Regulation: GEO / 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.
