Surgical Retractor Systems Suppliers
Limit companies to: Worldwide USA
Greatbatch Medical, Inc., | Address: 10000 Wehrle Drive, Clarence, New York 14031, USA 
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Amputation Saws, Cortical Screws, Dental Implants, Compression Screw, Cancellous Bone Screw, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Amputation Saws, Cortical Screws, Dental Implants, Compression Screw, Cancellous Bone Screw, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly 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...
Synthes (USA) | Address: 35 Airport Road, Horseheads, New York 14845, USA
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
Mediflexr Surgical Products | Address: 250 Gibbs Road, Islandia, New York 11749, USA
www.mediflex.com | Send Inquiry | Phone: +1-(631)-582-8440
FDA Registration: 2424366 Year Established: 1965 Annual Revenues: USD 10-25 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Scissors, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Table Mounted Systems, Tourniquet Machines, Cautery Instruments, ...
Mediflex® Surgical Products designs, manufactures & distributes surgical devices including laparoscopic holding & positioning devices, laparoscopic & table-mounted retractors & instruments for gen more...
www.mediflex.com | Send Inquiry | Phone: +1-(631)-582-8440
FDA Registration: 2424366 Year Established: 1965 Annual Revenues: USD 10-25 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Scissors, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Table Mounted Systems, Tourniquet Machines, Cautery Instruments, ...
Mediflex® Surgical Products designs, manufactures & distributes surgical devices including laparoscopic holding & positioning devices, laparoscopic & table-mounted retractors & instruments for gen more...
Oratronics, Inc. | Address: 405 Lexington Ave., New York, New York 10174, USA
Phone: +1-(212)-986-0050
Products: Bone Rongeurs, Periosteal Elevator, Periosteals Elevators, Scalpel Handle (FDA Code: GDZ), Tissue Retractors, Burr, ...
Oratronics, Inc. offers dental and surgical materials. Our products include abutment kit, bone rongeurs, endodontic stabilization kit, implant channeling burr, implant removers, needle holders, manual more...
Phone: +1-(212)-986-0050
Products: Bone Rongeurs, Periosteal Elevator, Periosteals Elevators, Scalpel Handle (FDA Code: GDZ), Tissue Retractors, Burr, ...
Oratronics, Inc. offers dental and surgical materials. Our products include abutment kit, bone rongeurs, endodontic stabilization kit, implant channeling burr, implant removers, needle holders, manual more...
Paradigm Spine, Llc | Address: 505 Park Ave, 14th Floor, New York, New York 10022, USA
www.paradigmspine.com | Send Inquiry | Phone: +1-(212)-583-9700
FDA Registration: 3005725110
Products: Spinal Implants, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP), Interspinous Implants, ...
Paradigm Spine, Llc is a provider of non-fusion spinal implant solutions. We offer Coflex™, an implant used in the treatment of facet arthrosis and de-compressive procedures. Our products are us more...
www.paradigmspine.com | Send Inquiry | Phone: +1-(212)-583-9700
FDA Registration: 3005725110
Products: Spinal Implants, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP), Interspinous Implants, ...
Paradigm Spine, Llc is a provider of non-fusion spinal implant solutions. We offer Coflex™, an implant used in the treatment of facet arthrosis and de-compressive procedures. Our products are us more...
Electro Surgical Instrument Co., Inc. | Address: 37 Centennial St., Rochester, New York 14611, USA
www.electrosurgicalinstrument.com | Send Inquiry | Phone: +1-(585)-235-1430, 888-464-2784
FDA Registration: 1315756 Year Established: 1896 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, Airways & Bite Blocks, Fiberoptic Intubating Airway, Adult Tongue Depressor (FDA Code: FMA), Adult Universal Bite Block, AC-Powered Transilluminator (FDA Code: HJM), ...
Electro Surgical Instrument Co., Inc.is a manufacturer of lighted medical instruments. Our products include lighting system components, neurosurgical instruments, nasal instruments, transilluminators, more...
www.electrosurgicalinstrument.com | Send Inquiry | Phone: +1-(585)-235-1430, 888-464-2784
FDA Registration: 1315756 Year Established: 1896 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, Airways & Bite Blocks, Fiberoptic Intubating Airway, Adult Tongue Depressor (FDA Code: FMA), Adult Universal Bite Block, AC-Powered Transilluminator (FDA Code: HJM), ...
Electro Surgical Instrument Co., Inc.is a manufacturer of lighted medical instruments. Our products include lighting system components, neurosurgical instruments, nasal instruments, transilluminators, more...
Closure Medical | Address: 5250 Greens Dairy Rd., Raleigh, North Carolina 27616, USA
Phone: +1-(919)-876-7800, 888-257-7633
Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Suture Free Wound Closure Adhesives, Wound Closure Adhesive (FDA Code: MGO), Vascular Device for Promoting Embolization (FDA Code: KRD), Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN), Waterproof Adhesive Strip, Ophthalmology Tissue Adhesive (FDA Code: LZQ), ...
Closure Medical are providers of nexacryl and n-butyl cyanoacrylate for treatment of corneal ulcerations. Dermabond is a topical skin adhesive. Nexaband family n-butyl cyanacrylate and 2-octyl cyanoac more...
Phone: +1-(919)-876-7800, 888-257-7633
Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Suture Free Wound Closure Adhesives, Wound Closure Adhesive (FDA Code: MGO), Vascular Device for Promoting Embolization (FDA Code: KRD), Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN), Waterproof Adhesive Strip, Ophthalmology Tissue Adhesive (FDA Code: LZQ), ...
Closure Medical are providers of nexacryl and n-butyl cyanoacrylate for treatment of corneal ulcerations. Dermabond is a topical skin adhesive. Nexaband family n-butyl cyanacrylate and 2-octyl cyanoac more...
Aris Medical | Address: 8000 Katherine Boulevard, Brecksville, Ohio 44141, USA
Phone: +1-(440)-262-6000
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Aris Medical specializes in surgical cannula and retractor systems. more...
Phone: +1-(440)-262-6000
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Aris Medical specializes in surgical cannula and retractor systems. more...
Kapp Surgical Instrument, Inc. | Address: 4919 Warrensville Center Rd., Cleveland, Ohio 44128, USA
www.kappsurgical.com | Send Inquiry | Phone: +1-(216)-587-4400, 800-282-5277
FDA Registration: 1522875 Year Established: 1927 Annual Revenues: USD 1-5 Million Quality: ISO 13485:2003 Certified
Products: Arthroscopy Shoulder Instrument Set, Genitourinary, Vasectomy Instruments, Aorta Clamp, Blade Retractor, Anterior Lumbar Spinal Retractor System, Disposable Surgical Instrument (FDA Code: KDC), ...
Kapp Surgical Instrument, Inc. manufactures custom designed stainless steel surgical instruments and implants. We offer adult renal clamps, special cone heparin needles, disjointed aneurysm clamps, su more...
www.kappsurgical.com | Send Inquiry | Phone: +1-(216)-587-4400, 800-282-5277
FDA Registration: 1522875 Year Established: 1927 Annual Revenues: USD 1-5 Million Quality: ISO 13485:2003 Certified
Products: Arthroscopy Shoulder Instrument Set, Genitourinary, Vasectomy Instruments, Aorta Clamp, Blade Retractor, Anterior Lumbar Spinal Retractor System, Disposable Surgical Instrument (FDA Code: KDC), ...
Kapp Surgical Instrument, Inc. manufactures custom designed stainless steel surgical instruments and implants. We offer adult renal clamps, special cone heparin needles, disjointed aneurysm clamps, su more...
Lexamed | Address: 705 Front St., Northwood, Ohio 43605, USA
lexamed.net | Send Inquiry | Phone: +1-(419)-693-5307, 888-232-5227
FDA Registration: 1525897
Products: Consulting Services, Surgical Retractor Systems (FDA Code: GAD), Quality Control Kits (FDA Code: JTR), Sterility Test Kits for Pharmaceutical Products, Tissue Culture Equipment, Culture Media Quality Control Kit (FDA Code: JTR), ...
Lexamed offers consulting services in all aspects of the pharmaceutical, medical and medical device & biotechnology industries. Our microbiological laboratory services include sterility testing, steri more...
lexamed.net | Send Inquiry | Phone: +1-(419)-693-5307, 888-232-5227
FDA Registration: 1525897
Products: Consulting Services, Surgical Retractor Systems (FDA Code: GAD), Quality Control Kits (FDA Code: JTR), Sterility Test Kits for Pharmaceutical Products, Tissue Culture Equipment, Culture Media Quality Control Kit (FDA Code: JTR), ...
Lexamed offers consulting services in all aspects of the pharmaceutical, medical and medical device & biotechnology industries. Our microbiological laboratory services include sterility testing, steri more...
Atricure, Inc. | Address: 6033 Schumacher Park Dr., West Chester, Ohio 45069, USA
www.atricure.com | Phone: +1-(513)-755-4130 866.349.2342
FDA Registration: 3003502395 Year Established: 2000
Products: Cryosurgical Unit (FDA Code: GEH), Electrode Recording Catheter (FDA Code: DRF), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Instrument Surgical Guide (FDA Code: FZX), For Ablation Of Cardiac Tissue Surgical Device (FDA Code: OCL), ...
Atricure, Inc. specializes in the development, manufacture and sales of cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac tissue. Coolrail™ linear pen is more...
www.atricure.com | Phone: +1-(513)-755-4130 866.349.2342
FDA Registration: 3003502395 Year Established: 2000
Products: Cryosurgical Unit (FDA Code: GEH), Electrode Recording Catheter (FDA Code: DRF), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Instrument Surgical Guide (FDA Code: FZX), For Ablation Of Cardiac Tissue Surgical Device (FDA Code: OCL), ...
Atricure, Inc. specializes in the development, manufacture and sales of cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac tissue. Coolrail™ linear pen is more...
Gorge Medical | Address: 902 12th Street, Hood River, Oregon 97031, USA
www.gorgemed.com | Send Inquiry | Phone: +1-(800)-354-8044
Products: Used Surgical Instruments, Surgical Retractor Systems (FDA Code: GAD), Bone Clamp (FDA Code: HXD), Surgical Retractor (FDA Code: GAD), Patient Position Support (FDA Code: CCX), Two-point Discriminator (FDA Code: GWI), ...
Gorge Medical offers a variety of surgical systems & screening tools useful to orthopedic surgeons, hand surgeons, occupational & physical therapists, nurses and other health-care professionals. The D more...
www.gorgemed.com | Send Inquiry | Phone: +1-(800)-354-8044
Products: Used Surgical Instruments, Surgical Retractor Systems (FDA Code: GAD), Bone Clamp (FDA Code: HXD), Surgical Retractor (FDA Code: GAD), Patient Position Support (FDA Code: CCX), Two-point Discriminator (FDA Code: GWI), ...
Gorge Medical offers a variety of surgical systems & screening tools useful to orthopedic surgeons, hand surgeons, occupational & physical therapists, nurses and other health-care professionals. The D more...
Medisiss | Address: 2747 Sw 6th Street, Redmond, Oregon 97756, USA
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
Aesculap Implant Systems, Inc. | Address: #3773, Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
Premier Products Co. | Address: 1710 Romano Drive, Plymouth Meeting, Pennsylvania 19462, USA
www.premusa.com | Send Inquiry | Phone: +1-(888)-239-6000
FDA Registration: 2521453 Year Established: 1980 Quality: ISO 9001, CE Certified
Products: Curettes, Retractors, Scissors, Electrosurgery, Enzymatic Detergents, Hemostats, ...
Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quie more...
www.premusa.com | Send Inquiry | Phone: +1-(888)-239-6000
FDA Registration: 2521453 Year Established: 1980 Quality: ISO 9001, CE Certified
Products: Curettes, Retractors, Scissors, Electrosurgery, Enzymatic Detergents, Hemostats, ...
Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quie more...
Swissortho Llc | Address: 18 Imperial Place, Suite 1g, Providence, Rhode Island 02903, USA
Phone: +1-(866)-8150604
FDA Registration: 3007887711
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Scalpel Blade (FDA Code: GES), Patient Position Support (FDA Code: CCX), ...
Swissortho Llc focuses on patient position supports, scalpel blades, surgical retractors and surgical retractor systems. more...
Phone: +1-(866)-8150604
FDA Registration: 3007887711
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Scalpel Blade (FDA Code: GES), Patient Position Support (FDA Code: CCX), ...
Swissortho Llc focuses on patient position supports, scalpel blades, surgical retractors and surgical retractor systems. more...
Tactical Medical Solutions, Inc. | Address: 112 North Park Drive, Anderson, South Carolina 29625, USA
www.tacmedsolutions.com | Send Inquiry | Phone: +1-(864)-224-0081, 888-822-6331
FDA Registration: 3005853033
Products: Surgical Retractor Systems (FDA Code: GAD), Bag Valve Mask, Surgical Retractor (FDA Code: GAD), General Surgical Scissors (FDA Code: LRW), Disposable Medical Scissors (FDA Code: JOK), Tourniquets, ...
Tactical Medical Solutions, Inc. develops & supplies equipment for combat and tactical medicine. Our products include hemorrhage control, airway/breathing, circulation, casualty evacuation and hypothe more...
www.tacmedsolutions.com | Send Inquiry | Phone: +1-(864)-224-0081, 888-822-6331
FDA Registration: 3005853033
Products: Surgical Retractor Systems (FDA Code: GAD), Bag Valve Mask, Surgical Retractor (FDA Code: GAD), General Surgical Scissors (FDA Code: LRW), Disposable Medical Scissors (FDA Code: JOK), Tourniquets, ...
Tactical Medical Solutions, Inc. develops & supplies equipment for combat and tactical medicine. Our products include hemorrhage control, airway/breathing, circulation, casualty evacuation and hypothe 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...
CSI Medical | Address: 170 Commerce Way, Gallatin, Tennessee 37066, USA
www.csimed.com | Send Inquiry | Phone: +1-(615)-452-9633
FDA Registration: 2320386 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001:2000 Certified
Products: Pulse Oximetry, Wound Care, Medical Labels, Faceshields, Contract Manufacturing, Contract Packaging, ...
CSI Medical offers global solutions for all manufacturing and packaging needs. Our product line capabilities include skin contact devices, surgical face shields, equipment drape tape components, patie more...
www.csimed.com | Send Inquiry | Phone: +1-(615)-452-9633
FDA Registration: 2320386 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001:2000 Certified
Products: Pulse Oximetry, Wound Care, Medical Labels, Faceshields, Contract Manufacturing, Contract Packaging, ...
CSI Medical offers global solutions for all manufacturing and packaging needs. Our product line capabilities include skin contact devices, surgical face shields, equipment drape tape components, patie more...
Sponsored Links
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.
