Orthopedic Cutting Instrument Suppliers
Limit companies to: Worldwide USA
HEBUmedical GmbH | Address: Badstrasse 8, Tuttlingen D-78532, Germany 
www.hebumedical.de | Send Inquiry | Phone: +49-(7461)-94 710
FDA Registration: 9611112
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), ...
HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as t more...
www.hebumedical.de | Send Inquiry | Phone: +49-(7461)-94 710
FDA Registration: 9611112
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), ...
HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as t more...
Diwymed Production Gmbh | Address: By Hassler 5, Tuttlingen 78532, Germany
Send Inquiry | Phone: +49-(7462)-200116
FDA Registration: 9680938
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Diwymed Production Gmbh offers surgical retractors, probes, pliers, surgical hammers, retainers, medical rasps and bone hooks. more...
Send Inquiry | Phone: +49-(7462)-200116
FDA Registration: 9680938
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Diwymed Production Gmbh offers surgical retractors, probes, pliers, surgical hammers, retainers, medical rasps and bone hooks. more...
Vehu Medical Gmbh | Address: 48 Semmelweisstraße, Tuttlingen 78532, Germany
www.vehu.com | Send Inquiry | Phone: +49-(7461)-163311
FDA Registration: 9616246
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, ...
Vehu Medical Gmbh provides surgical accessory applicator, cotton, forceps, extractor, scissors, ophthalmic fork, syringe, retractor, stethoscopes, head mirrors, needles, dissector, surgical clip, oper more...
www.vehu.com | Send Inquiry | Phone: +49-(7461)-163311
FDA Registration: 9616246
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, ...
Vehu Medical Gmbh provides surgical accessory applicator, cotton, forceps, extractor, scissors, ophthalmic fork, syringe, retractor, stethoscopes, head mirrors, needles, dissector, surgical clip, oper more...
Gebrüder Martin GmbH & Co. KG, | Address: Ludwigstaler Str 132, Tuttlingen 78532, Germany
www.martin-med.com | Phone: +49-(7461)-706-343
FDA Registration: 8010168 Annual Revenues: < USD 1 Million Employee Count: ~700 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosu more...
www.martin-med.com | Phone: +49-(7461)-706-343
FDA Registration: 8010168 Annual Revenues: < USD 1 Million Employee Count: ~700 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosu more...
Christian Diener GmbH & Co KG | Address: Rudolf-Diesel-Str. 18, Tuttlingen 78532, Germany
www.diener-gmbh.de | Send Inquiry | Phone: +49-(7461)-965823
FDA Registration: 9611813
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Forceps Needle Holders, ...
Christian Diener GmbH & Co KG offers surgical instruments for all types of surgery. more...
www.diener-gmbh.de | Send Inquiry | Phone: +49-(7461)-965823
FDA Registration: 9611813
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Forceps Needle Holders, ...
Christian Diener GmbH & Co KG offers surgical instruments for all types of surgery. more...
Idea-Instrumentefabrik Berchtold & Co. GmbH | Address: Weimarstr 13-15, Tuttlingen 78532, Germany
Phone: +49-(7461)-2345
FDA Registration: 8010153 Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Idea-Instrumentefabrik Berchtold & Co. GmbH specializes in the manufacture and export of medical & dental instruments. Our products include dental impression trays, hemostats, uterine dilators, dental more...
Phone: +49-(7461)-2345
FDA Registration: 8010153 Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Idea-Instrumentefabrik Berchtold & Co. GmbH specializes in the manufacture and export of medical & dental instruments. Our products include dental impression trays, hemostats, uterine dilators, dental more...
Dimeda Instrumente Gmbh | Address: Gansacker 54+58, Tuttlingen 78532, Germany
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
RZ-Medizintechnik Gmbh | Address: Unter Hasslen 20, Tuttlingen 78532, Germany
www.rz-medizintechnik.com | Phone: +49-(7462)-9470-0
FDA Registration: 9680718 Quality: ISO 9001, EN 46001, DIN EN ISO:13485,CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
RZ-Medizintechnik GmbH offers standard and speciality instruments & accessories for various surgical fields such as arthroscopy, ENT, urology, ophthalmology, & plastic surgery. We offer a complete set more...
www.rz-medizintechnik.com | Phone: +49-(7462)-9470-0
FDA Registration: 9680718 Quality: ISO 9001, EN 46001, DIN EN ISO:13485,CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
RZ-Medizintechnik GmbH offers standard and speciality instruments & accessories for various surgical fields such as arthroscopy, ENT, urology, ophthalmology, & plastic surgery. We offer a complete set more...
Erchinger Medizintecnik | Address: Rudolf-Diesel-Str. 20, Tuttlingen 78532, Germany
Phone: +49-(7461)-3243
FDA Registration: 9611827
Products: Probes (FDA Code: HXB), Uterine Sound Instruments, Bone Rasps (FDA Code: HTR), Urethral Catheters (FDA Code: GBM), Uterine Sound Devices, Urological Catheters (FDA Code: KOD), ...
Erchinger Medizintecnik specializes in offering hemorrhoidal suction ligators. Our products include ENT injection syringes, urological catheters, ENT suction tube, surgical needle guides, trocars for more...
Phone: +49-(7461)-3243
FDA Registration: 9611827
Products: Probes (FDA Code: HXB), Uterine Sound Instruments, Bone Rasps (FDA Code: HTR), Urethral Catheters (FDA Code: GBM), Uterine Sound Devices, Urological Catheters (FDA Code: KOD), ...
Erchinger Medizintecnik specializes in offering hemorrhoidal suction ligators. Our products include ENT injection syringes, urological catheters, ENT suction tube, surgical needle guides, trocars for more...
Karl Storz GmbH & Co. KG. | Address: Mittelstr. 8, 78532 Tuttlingen, Postfach 230, Tuttlingen 78503, Germany
www.karlstorz.com | Send Inquiry | Phone: +49-(7461)-708-0
FDA Registration: 9614434 Employee Count: ~2000 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Cameras, Video & Optical Systems, Forceps (FDA Code: HTD), Retractors, Light Sources, Endoscopes, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applicatio more...
www.karlstorz.com | Send Inquiry | Phone: +49-(7461)-708-0
FDA Registration: 9614434 Employee Count: ~2000 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Cameras, Video & Optical Systems, Forceps (FDA Code: HTD), Retractors, Light Sources, Endoscopes, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applicatio more...
Tumed Surgical Instruments & Hospital Supplies Gmb | Address: Rotwildstr. 20 - 22, Tuttlingen 78532, Germany
Phone: +49-(746)-1965880
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Scalpel Handle (FDA Code: GDZ), Tonsil Snares (FDA Code: KBZ), ...
Tumed Surgical Instruments & Hospital Supplies Gmb provides various surgical and medical equipments. Our product line includes rectal speculums, nasal rasps, microsurgical ear hooks, ear speculum, ear more...
Phone: +49-(746)-1965880
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Scalpel Handle (FDA Code: GDZ), Tonsil Snares (FDA Code: KBZ), ...
Tumed Surgical Instruments & Hospital Supplies Gmb provides various surgical and medical equipments. Our product line includes rectal speculums, nasal rasps, microsurgical ear hooks, ear speculum, ear more...
E.G. Vorling Kg | Address: Im Jungen Steigle 5, Tuttlingen D-78532, Germany
Phone: +49-(746)-13335
FDA Registration: 9611374
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Foley Catheter Holders (FDA Code: EYJ), ...
E.G. Vorling Kg deals with various surgical and medical equipments. Our products include surgical clamps, orthopedic needle holders, surgical scissors, ureteral catheter holder, bone clamp, and orthop more...
Phone: +49-(746)-13335
FDA Registration: 9611374
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Foley Catheter Holders (FDA Code: EYJ), ...
E.G. Vorling Kg deals with various surgical and medical equipments. Our products include surgical clamps, orthopedic needle holders, surgical scissors, ureteral catheter holder, bone clamp, and orthop more...
Aesculap Ag | Address: 1120, Tuttlingen, Donau D-78532, Germany
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
Gimmi GmbH | Address: Carl-Zeiss-Strasse 6, Tuttlingen, Baden-Wuerttemberg D-78532, Germany
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Yasargil Aneurysm Clips, Self-Retaining Retractors (FDA Code: FFO), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Yasargil Aneurysm Clips, Self-Retaining Retractors (FDA Code: FFO), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
Kapp Surgical GmbH | Address: Hauptstr 5, Duerbheim, Kr Tuttlingen 78589, Germany
www.kapp-germany.de | Send Inquiry | Phone: +49-(7424)-94-03-0
FDA Registration: 8010769 Year Established: 1982 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Nasal Scissors Straight (FDA Code: KBD), ...
Kapp Surgical GmbH offers surgical products such as laminectomy rongeurs, intervertebral ronguers, jaws, bone rongeurs, bone cutting forceps, and wire cutting pliers. more...
www.kapp-germany.de | Send Inquiry | Phone: +49-(7424)-94-03-0
FDA Registration: 8010769 Year Established: 1982 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Nasal Scissors Straight (FDA Code: KBD), ...
Kapp Surgical GmbH offers surgical products such as laminectomy rongeurs, intervertebral ronguers, jaws, bone rongeurs, bone cutting forceps, and wire cutting pliers. more...
Jakoubek | Address: Auf der Höhe 15, Liptingen, Tuttlingen D-78576, Germany
www.jakoubek.com | Send Inquiry | Phone: +49-(7465)-9264-0
FDA Registration: 9612277
Products: Probes (FDA Code: HXB), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Reusable Bipolar Forceps, ...
Jakoubek supplies advanced surgical equipment. Our flexible gastro-intestinal product line comprises of biopsy forceps, probes, catheter and stone removal forceps. Our laparoscopy product line compris more...
www.jakoubek.com | Send Inquiry | Phone: +49-(7465)-9264-0
FDA Registration: 9612277
Products: Probes (FDA Code: HXB), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Reusable Bipolar Forceps, ...
Jakoubek supplies advanced surgical equipment. Our flexible gastro-intestinal product line comprises of biopsy forceps, probes, catheter and stone removal forceps. Our laparoscopy product line compris more...
Medicrea | Address: Z.I. Chef De Baie, La Rochelle 17000, France
FDA Registration: 1000432246
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Medicrea supplies surgical, orthopedic and spinal products. Our products include lumbar intervertebral fusion devices with bone grafts, spinal interlaminal fixation appliances, spondylolisthesis spina more...
FDA Registration: 1000432246
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Medicrea supplies surgical, orthopedic and spinal products. Our products include lumbar intervertebral fusion devices with bone grafts, spinal interlaminal fixation appliances, spondylolisthesis spina more...
Lifecare Surgical | Address: Nasr City Free Industrial Zone, Area 3, Block B, Nasr City 11816, Egypt
www.lifecaresi.com | Send Inquiry | Phone: +20-(2)-26720314
Quality: ISO 13485:2003 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
Lifecare Surgical focuses on general surgical, dental, veterinary, and electro surgical instruments. We provide knives, scalpels, suture, forceps, probes, spatula, cotton carriers, suction tubes, and more...
www.lifecaresi.com | Send Inquiry | Phone: +20-(2)-26720314
Quality: ISO 13485:2003 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
Lifecare Surgical focuses on general surgical, dental, veterinary, and electro surgical instruments. We provide knives, scalpels, suture, forceps, probes, spatula, cotton carriers, suction tubes, and more...
Allegiance Healthcare Corp. | Address: Zona Franca Las Americas, Autlas Americas Km 22 1-2 Sur, Santo Domingo, Dominican Republic
Phone: 847-473-1500
FDA Registration: 9680904
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Phone: 847-473-1500
FDA Registration: 9680904
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Beznoska s.r.o | Address: 2727 Delnicka, Kladno 27201, Czech Republic
www.beznoska.cz | Send Inquiry | Phone: +420-(312)-660670/602-666503
Products: Orthopedic Cutting Instrument (FDA Code: HTZ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Smooth Fixation Pin (FDA Code: HTY), ...
Beznoska s.r.o. manufactures implants, tools and surgical utensils for orthopedic surgery & traumatology. Our product area includes cementless hip joint replacements, cemented hip joint replacements, more...
www.beznoska.cz | Send Inquiry | Phone: +420-(312)-660670/602-666503
Products: Orthopedic Cutting Instrument (FDA Code: HTZ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Smooth Fixation Pin (FDA Code: HTY), ...
Beznoska s.r.o. manufactures implants, tools and surgical utensils for orthopedic surgery & traumatology. Our product area includes cementless hip joint replacements, cemented hip joint replacements, more...
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FDA Code / Regulation: HTZ / 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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