Reusable Aspiration and Injection Needle Suppliers
Limit companies to: Worldwide USA
Byron Medical, Inc. | Address: 602 W. Rillito, Tucson, Arizona 85705, USA 
www.byrondirect.com | Send Inquiry | Phone: +1-(520)-573-0857, 800-777-3434
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Desmarres Lid Retractors, Jaeger Lid Plates, Goggles & Protective Eyewear, IV Catheters & Infusion Sets, General Medical Supplies, General Surgical Aids, ...
Byron Medical, Inc. introduced ActiPatch™, which is a new innovation in micro electrical therapy. Our alpha infusion pumps comes in two sizes, the 200ml and the 450 ml, thus offering the physici more...
www.byrondirect.com | Send Inquiry | Phone: +1-(520)-573-0857, 800-777-3434
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001, CE Certified
Products: Desmarres Lid Retractors, Jaeger Lid Plates, Goggles & Protective Eyewear, IV Catheters & Infusion Sets, General Medical Supplies, General Surgical Aids, ...
Byron Medical, Inc. introduced ActiPatch™, which is a new innovation in micro electrical therapy. Our alpha infusion pumps comes in two sizes, the 200ml and the 450 ml, thus offering the physici more...
Sontec Instruments, Inc. | Address: 7248 South Tucson Way, Colorado 80112, USA
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
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...
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...
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...
Ranfac Corp. | Address: 30 Doherty Avenue, P.O. Box 635, Avon, Massachusetts 02322, USA
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Stainless Steel Brain Biopsy Needles, Cholangiography Catheters (FDA Code: GBZ), Pneumoperitoneum Insufflation Needle, Multipurpose Knot Pusher Ligator, Soft Tissue Biopsy Needles, Percutaneous Introducer, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Stainless Steel Brain Biopsy Needles, Cholangiography Catheters (FDA Code: GBZ), Pneumoperitoneum Insufflation Needle, Multipurpose Knot Pusher Ligator, Soft Tissue Biopsy Needles, Percutaneous Introducer, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
Scanlan International | Address: One Scanlan Plaza, St. Paul, Minnesota 55107, USA
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Dutch Ophthalmic USA | Address: 10 Continental Drive, Bldg 1, Exeter, New Hampshire 03833, USA
www.dorc.nl | Send Inquiry | Phone: +1-(603)-778-6929
FDA Registration: 1222074 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Phacoemulsification Systems, Retinal Forceps, Gases, Oils, Liquids, Zenoni angled Retinal Forceps, End Gripping Retinal Forceps, Titanium RETINAL Forceps, ...
Dutch Ophthalmic USA provides ophthalmic surgeons with instruments & equipment designed specifically for the demanding needs of phacoemulsification and vitreoretinal surgery. Our products include surg more...
www.dorc.nl | Send Inquiry | Phone: +1-(603)-778-6929
FDA Registration: 1222074 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Phacoemulsification Systems, Retinal Forceps, Gases, Oils, Liquids, Zenoni angled Retinal Forceps, End Gripping Retinal Forceps, Titanium RETINAL Forceps, ...
Dutch Ophthalmic USA provides ophthalmic surgeons with instruments & equipment designed specifically for the demanding needs of phacoemulsification and vitreoretinal surgery. Our products include surg more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
Fujinon, Inc. | Address: 10 High Point Drive, Wayne, New Jersey 07470, USA
www.fujinonendoscopy.com | Send Inquiry | Phone: +1-(800)-490-0661
FDA Registration: 2431293 Quality: ISO 9000 Certified
Products: Laryngoscopes, Fiberoptic Bronchoscopes, Articulating Tip Laryngoscopes, Fiber Optic Blade Laryngoscopes, Conventional Laryngoscopes, Fiberoptic Laryngoscopes, ...
Fujinon, Inc. supplies endoscopic equipment. We offer the latest in endoscopic solutions for outpatient facilities, hospitals and teaching institutions. Our most advanced G-5™ endoscopes are now more...
www.fujinonendoscopy.com | Send Inquiry | Phone: +1-(800)-490-0661
FDA Registration: 2431293 Quality: ISO 9000 Certified
Products: Laryngoscopes, Fiberoptic Bronchoscopes, Articulating Tip Laryngoscopes, Fiber Optic Blade Laryngoscopes, Conventional Laryngoscopes, Fiberoptic Laryngoscopes, ...
Fujinon, Inc. supplies endoscopic equipment. We offer the latest in endoscopic solutions for outpatient facilities, hospitals and teaching institutions. Our most advanced G-5™ endoscopes are now 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...
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...
Surgical Specialties Corporation | Address: 100 Dennis Drive, Reading, Pennsylvania 19606, USA
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Absorbable Surgical Sutures, Dissolving Sutures, Dissolvable Sutures, Surgical Non Absorbable Sutures, Surgical Sutures, ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Absorbable Surgical Sutures, Dissolving Sutures, Dissolvable Sutures, Surgical Non Absorbable Sutures, Surgical Sutures, ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer 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...
Wells Johnson Company | Address: 8000 South Kolb Road, Tucson, Arizona 85706-9104, USA
www.wellsgrp.com | Send Inquiry | Phone: +1-(520)-298-6069, (800)-528-1597
FDA Registration: 2024022 Year Established: 1980 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Aspirators, Dual Head Infusion Systems, Single Head Infusion Systems, Micro Cannula Sets, Spike Infusion Tubing, Peristaltic Infusion Pump (FDA Code: FRN), ...
Wells Johnson Company focuses on development and implementation of aspiration & infusion equipment into the medical market. Our product categories include aspirators, infusion systems, cannulas, re-in more...
www.wellsgrp.com | Send Inquiry | Phone: +1-(520)-298-6069, (800)-528-1597
FDA Registration: 2024022 Year Established: 1980 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Aspirators, Dual Head Infusion Systems, Single Head Infusion Systems, Micro Cannula Sets, Spike Infusion Tubing, Peristaltic Infusion Pump (FDA Code: FRN), ...
Wells Johnson Company focuses on development and implementation of aspiration & infusion equipment into the medical market. Our product categories include aspirators, infusion systems, cannulas, re-in more...
Allwin Medical Devices, Inc. | Address: 3305 E. Miraloma Avenue, Suite 176, Anaheim, California 92806, USA
www.allwinmedical.com | Send Inquiry | Phone: +1-(714)-572-1709
FDA Registration: 3005987240 Quality: ISO 9001, ISO 13485 Certified
Products: Grasping Forceps, Balloon Ureteral Dilators, Biliary Stents, Breast Localization Needle, Core Tissue Biopsy Needles, Fascial Dilator Set, ...
Allwin Medical Devices, Inc. manufactures urology products. Our urology products include biopsy needles, dilators, guidewires, stone buster pneumatic lithotripters, meatal dilators and urinary diversi more...
www.allwinmedical.com | Send Inquiry | Phone: +1-(714)-572-1709
FDA Registration: 3005987240 Quality: ISO 9001, ISO 13485 Certified
Products: Grasping Forceps, Balloon Ureteral Dilators, Biliary Stents, Breast Localization Needle, Core Tissue Biopsy Needles, Fascial Dilator Set, ...
Allwin Medical Devices, Inc. manufactures urology products. Our urology products include biopsy needles, dilators, guidewires, stone buster pneumatic lithotripters, meatal dilators and urinary diversi more...
Stemcor Systems, Inc. | Address: 801 Hermosa Way, Menlo Park, California 94025, USA
stemcorsystems.com | Send Inquiry | Phone: +1-(650)-3216884
Products: Bone Marrow Aspiration Needle with Adjustable Needle Stop, Disposable Aspiration and Injection Needle (FDA Code: GAA), Reusable Aspiration and Injection Needle (FDA Code: GDM), ...
Stemcor Systems, Inc. develops technologies for regenerative medicine. Our product line includes Marrowminer® and Marrowselect®. Our Marrowminer® harvests bone marrow in a minimally-invasi more...
stemcorsystems.com | Send Inquiry | Phone: +1-(650)-3216884
Products: Bone Marrow Aspiration Needle with Adjustable Needle Stop, Disposable Aspiration and Injection Needle (FDA Code: GAA), Reusable Aspiration and Injection Needle (FDA Code: GDM), ...
Stemcor Systems, Inc. develops technologies for regenerative medicine. Our product line includes Marrowminer® and Marrowselect®. Our Marrowminer® harvests bone marrow in a minimally-invasi more...
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FDA Code / Regulation: GDM / 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.
