Cardiovascular Biopsy Needle Suppliers
Limit companies to: Worldwide USA
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...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo 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...
Integra Radionics, Inc. | Address: 22 Terry Avenue, Burlington, Massachusetts 01803, USA
www.radionics.com | Send Inquiry | Phone: +1-(781)-272-1233, 800-466-6814
FDA Registration: 1222895 Year Established: 1938 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Surgical Navigation Interface/Display, Stereotactic Frame, Deep Brain Stimulators, Planning Software, Micro Recording Systems, Fluoroscopy Systems, ...
Integra Radionics, Inc. produces surgical devices in the fields of neurosurgery and radiation therapy by combining technical & clinical experience. Our Cusa EXcel™ system renders a powerful comb more...
www.radionics.com | Send Inquiry | Phone: +1-(781)-272-1233, 800-466-6814
FDA Registration: 1222895 Year Established: 1938 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Surgical Navigation Interface/Display, Stereotactic Frame, Deep Brain Stimulators, Planning Software, Micro Recording Systems, Fluoroscopy Systems, ...
Integra Radionics, Inc. produces surgical devices in the fields of neurosurgery and radiation therapy by combining technical & clinical experience. Our Cusa EXcel™ system renders a powerful comb more...
Syneture | Address: 15 Hampshire St., Mansfield, Massachusetts 02048, USA
www.syneture.com | Send Inquiry | Phone: +1-(508)-261-8000
Products: Chronic Total Occlusion Devices, Absorbable Sutures (FDA Code: GAK), Bone Wax (FDA Code: MTJ), Absorbable Tissue Adhesive, Cardiovascular Biopsy Needle (FDA Code: DWO), Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK), ...
Syneture deals with a wide range of absorbable & non-absorbable sutures, bio surgery, suture needles, surgical mesh and surgical accessories. Our key product categories are cardiovascular surgery, gen more...
www.syneture.com | Send Inquiry | Phone: +1-(508)-261-8000
Products: Chronic Total Occlusion Devices, Absorbable Sutures (FDA Code: GAK), Bone Wax (FDA Code: MTJ), Absorbable Tissue Adhesive, Cardiovascular Biopsy Needle (FDA Code: DWO), Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK), ...
Syneture deals with a wide range of absorbable & non-absorbable sutures, bio surgery, suture needles, surgical mesh and surgical accessories. Our key product categories are cardiovascular surgery, gen more...
Vita Needle Co., Inc. | Address: 919 Great Plain Avenue, Needham, Massachusetts 02492, USA
www.vitaneedle.com | Send Inquiry | Phone: +1-(781)-444-1780
FDA Registration: 1213680 Year Established: 1932 Annual Revenues: USD 1-5 Million Employee Count: ~30
Products: Hypodermic Needles, Needles, Disposable Needles, Needles & Guidance Systems, Needles & Needle Guides, Needles & Needle Guidance Systems, ...
Vita Needle Co., Inc. offers reusable needles and dispersing syringes. Our disposable SS needle blunts are standard dispensing needles made out of stainless steel cannula and a polypropylene hub. They more...
www.vitaneedle.com | Send Inquiry | Phone: +1-(781)-444-1780
FDA Registration: 1213680 Year Established: 1932 Annual Revenues: USD 1-5 Million Employee Count: ~30
Products: Hypodermic Needles, Needles, Disposable Needles, Needles & Guidance Systems, Needles & Needle Guides, Needles & Needle Guidance Systems, ...
Vita Needle Co., Inc. offers reusable needles and dispersing syringes. Our disposable SS needle blunts are standard dispensing needles made out of stainless steel cannula and a polypropylene hub. They more...
Medtronic, Inc. | Address: 710 Medtronic Parkway, Minneapolis, Minnesota 55432-5604, USA
www.medtronic.com | Send Inquiry | Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: EMG Electrodes, Bioprosthesis, Pulmonary Valved Conduit, Transcatheter Pulmonary Valve, Transcatheter Delivery System, Single Fiber EMG Software, Non-invasive Magnetic Stimulation System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu more...
www.medtronic.com | Send Inquiry | Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: EMG Electrodes, Bioprosthesis, Pulmonary Valved Conduit, Transcatheter Pulmonary Valve, Transcatheter Delivery System, Single Fiber EMG Software, Non-invasive Magnetic Stimulation System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu more...
E-Z-EM Inc. | Address: 1111 Marcus Avenue Suite LL26, Lake Success, New York 11042, USA
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, Contrast Media, Disposable Needles, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our more...
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, Contrast Media, Disposable Needles, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our 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...
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...
PneumRx | Address: 530 Logue Ave, Mountain View, California 94043, USA
www.pneumrx.com | Phone: +1-(650)-625-8910
FDA Registration: 3005823838
Products: Needles, Biopsy Forceps, Biopsy Instruments (FDA Code: KNW), Medical Devices, Cardiovascular Biopsy Needle (FDA Code: DWO), General Medical Device, ...
PneumRx develops, manufactures and provides innovative devices for the treatment of emphysema patients. Our products include sterile & non-sterile needles, and biopsy forceps. more...
www.pneumrx.com | Phone: +1-(650)-625-8910
FDA Registration: 3005823838
Products: Needles, Biopsy Forceps, Biopsy Instruments (FDA Code: KNW), Medical Devices, Cardiovascular Biopsy Needle (FDA Code: DWO), General Medical Device, ...
PneumRx develops, manufactures and provides innovative devices for the treatment of emphysema patients. Our products include sterile & non-sterile needles, and biopsy forceps. more...
Corventis, Inc. | Address: 2033 Gateway Place, Suite 100, San Jose, California 95110, USA
Send Inquiry | Phone: +1-(408)-7909300
Products: Cardiovasculars, Cardiovascular Systems, Arrhythmia Detector and Alarm (FDA Code: DSI), Cardiovascular Biopsy Needle (FDA Code: DWO), Cardiovascular Scissors, Cardiovascular Suture (FDA Code: DTH), ...
Corventis, Inc. develops wireless cardiovascular solutions designed to enable early detection, prevention and treatment of cardiovascular conditions. Our products include home healthcare monitor devic more...
Send Inquiry | Phone: +1-(408)-7909300
Products: Cardiovasculars, Cardiovascular Systems, Arrhythmia Detector and Alarm (FDA Code: DSI), Cardiovascular Biopsy Needle (FDA Code: DWO), Cardiovascular Scissors, Cardiovascular Suture (FDA Code: DTH), ...
Corventis, Inc. develops wireless cardiovascular solutions designed to enable early detection, prevention and treatment of cardiovascular conditions. Our products include home healthcare monitor devic more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
Sabin Corporation | Address: 3800 Constitution Avenue, PO Box 788, Bloomington, Indiana 47402, USA
www.sabincorp.com | Send Inquiry | Phone: +1-(812)-323-4500, 800-264-4510
Year Established: 1969 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 13485 Certified
Products: Injection Molded Parts, Plastic Tubing, Cardiovascular Biopsy Needle (FDA Code: DWO), ...
Sabin Corporation deals with custom plastic processing. We manufacture preformed plastic tubing, injection molded, insert molded and thermoformed parts. Our materials are used in medical products. more...
www.sabincorp.com | Send Inquiry | Phone: +1-(812)-323-4500, 800-264-4510
Year Established: 1969 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 13485 Certified
Products: Injection Molded Parts, Plastic Tubing, Cardiovascular Biopsy Needle (FDA Code: DWO), ...
Sabin Corporation deals with custom plastic processing. We manufacture preformed plastic tubing, injection molded, insert molded and thermoformed parts. Our materials are used in medical products. more...
CIVCO Medical Solutions | Address: 102 First Street South, Kalona, Iowa 52247-9589, USA
www.civco.com | Send Inquiry | Phone: +001-(319)-656-4447, 800-445-6741
FDA Registration: 1937223 Year Established: 1981 Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: General Surgery Supplies, Medical Ultrasound Devices, Positioning System Accessories, Printer Accessories, Printers, Intensity Modulated Radiation Therapy Accessories, ...
CIVCO Medical Solutions designs, manufactures & distributes medical products for ultrasound and minimally invasive surgical equipment & procedures. Our clinical specialties are radiation oncology, gen more...
www.civco.com | Send Inquiry | Phone: +001-(319)-656-4447, 800-445-6741
FDA Registration: 1937223 Year Established: 1981 Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: General Surgery Supplies, Medical Ultrasound Devices, Positioning System Accessories, Printer Accessories, Printers, Intensity Modulated Radiation Therapy Accessories, ...
CIVCO Medical Solutions designs, manufactures & distributes medical products for ultrasound and minimally invasive surgical equipment & procedures. Our clinical specialties are radiation oncology, gen more...
Hart Enterprises, Inc. | Address: 400 Applejack Ct., Sparta, Michigan 49345, USA
www.hartneedles.com | Send Inquiry | Phone: +1-(616)-887-0400
FDA Registration: 1828424 Year Established: 1976 Annual Revenues: USD 5-10 Million Employee Count: ~80
Products: Hypodermic Needles, Spinal Needles, Cannulas, Packaging, Guide Wire Introducer Needles, Biopsy Needle Kit (FDA Code: FCG), ...
Hart Enterprises, Inc. offers medical products such as guidewire introducers, biopsy needles and spinal needles. The Chiba biopsy needle is a fine-needle percutaneous, soft-tissue, aspiration biopsy i more...
www.hartneedles.com | Send Inquiry | Phone: +1-(616)-887-0400
FDA Registration: 1828424 Year Established: 1976 Annual Revenues: USD 5-10 Million Employee Count: ~80
Products: Hypodermic Needles, Spinal Needles, Cannulas, Packaging, Guide Wire Introducer Needles, Biopsy Needle Kit (FDA Code: FCG), ...
Hart Enterprises, Inc. offers medical products such as guidewire introducers, biopsy needles and spinal needles. The Chiba biopsy needle is a fine-needle percutaneous, soft-tissue, aspiration biopsy i more...
Multi-Med, Inc. | Address: Winchester St., P.O. Box 660, West Swanzey, New Hampshire 03469, USA
www.multimedinc.com | Send Inquiry | Phone: +1-(603)-357-8733
FDA Registration: 1221765 Annual Revenues: < USD 1 Million
Products: Feeding Tubes (FDA Code: FPD), Cardiovascular Biopsy Needle (FDA Code: DWO), Continuous Electronic Thermometer (FDA Code: FLL), Disposable Product Contract Manufacturing, Elastomeric Infusion Pump (FDA Code: MEB), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Multi-Med, Inc. is a manufacturer and packager of custom medical disposables. We specialize in the packaging of custom medical disposables such as extension and administration sets. We produce sub-Q, more...
www.multimedinc.com | Send Inquiry | Phone: +1-(603)-357-8733
FDA Registration: 1221765 Annual Revenues: < USD 1 Million
Products: Feeding Tubes (FDA Code: FPD), Cardiovascular Biopsy Needle (FDA Code: DWO), Continuous Electronic Thermometer (FDA Code: FLL), Disposable Product Contract Manufacturing, Elastomeric Infusion Pump (FDA Code: MEB), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Multi-Med, Inc. is a manufacturer and packager of custom medical disposables. We specialize in the packaging of custom medical disposables such as extension and administration sets. We produce sub-Q, more...
Popper & Sons Inc | Address: 300 Denton Ave, New Hyde Park, New York 11040-3437, USA
www.popperandsons.com | Send Inquiry | Phone: +001-(516)-248-0300
Year Established: 1922 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Biopsy Supplies, Disposable Needles, Disposable Syringes, IV Sets, General Medical Supplies, General Hypodermic Supplies, ...
Popper & Sons Inc supplies a wide range of reusable & specialty hypodermic products to the medical & laboratory markets. Our product line comprises of hypodermic & procedure needles, which include ane more...
www.popperandsons.com | Send Inquiry | Phone: +001-(516)-248-0300
Year Established: 1922 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Biopsy Supplies, Disposable Needles, Disposable Syringes, IV Sets, General Medical Supplies, General Hypodermic Supplies, ...
Popper & Sons Inc supplies a wide range of reusable & specialty hypodermic products to the medical & laboratory markets. Our product line comprises of hypodermic & procedure needles, which include ane more...
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FDA Code / Regulation: DWO / 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.
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