Surgical Curette Suppliers
Limit companies to: Worldwide USA
Koros Usa, Inc. | Address: 610 Flinn Ave., Moorpark, California 93021, USA 
www.korosusa.com | Send Inquiry | Phone: +1-(805)-529-0825
FDA Registration: 2023918
Products: Probes (FDA Code: HXB), Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), Cervical Retractor System, ...
Koros Usa, Inc. is a supplier of surgical instruments. Our product line includes cardio & thoracic, neuro and orthopedic instruments, pro retractor sets, V-Track retractor sets & XL instruments. Our c more...
www.korosusa.com | Send Inquiry | Phone: +1-(805)-529-0825
FDA Registration: 2023918
Products: Probes (FDA Code: HXB), Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), Cervical Retractor System, ...
Koros Usa, Inc. is a supplier of surgical instruments. Our product line includes cardio & thoracic, neuro and orthopedic instruments, pro retractor sets, V-Track retractor sets & XL instruments. Our c more...
Seaspine | Address: 2302 La Mirada Drive, Vista, California 92081-7862, USA
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
Lenox Maclaren | Address: 657 S. Taylor Avenue, Suite A, Louisville, Colorado 80027, USA
www.lenoxmaclaren.com | Send Inquiry | Phone: +1-(866)-890-9660
FDA Registration: 1722824 Year Established: 1983 Annual Revenues: USD 1-5 Million
Products: Curettes, Elevators, Probes (FDA Code: HXB), Wire Twisters (FDA Code: HXS), Instruments surgical, Bone Taps (FDA Code: HWX), ...
Lenox Maclaren specializes in custom instrument design and fabricatrion. Our product list comprises of bone mills, table top rod cutter, retractors, and instrument sterilization trays. Our bone mill i more...
www.lenoxmaclaren.com | Send Inquiry | Phone: +1-(866)-890-9660
FDA Registration: 1722824 Year Established: 1983 Annual Revenues: USD 1-5 Million
Products: Curettes, Elevators, Probes (FDA Code: HXB), Wire Twisters (FDA Code: HXS), Instruments surgical, Bone Taps (FDA Code: HWX), ...
Lenox Maclaren specializes in custom instrument design and fabricatrion. Our product list comprises of bone mills, table top rod cutter, retractors, and instrument sterilization trays. Our bone mill i more...
Acuderm, Inc | Address: 5370 NW Terrace, Fort Lauderdale, Florida 33309, USA
acuderm.com | Send Inquiry | Phone: +001-(800)-327-0015
FDA Registration: 1035236 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Punches (FDA Code: FCI), Cauteries, Cold Sterilization Solution, ...
Acuderm, Inc markets quality specialty medical products, disposable instruments and dermatology supplies. Our product line includes punches, curettes, acu excisor, needle, syringes, sutures, hyfrecato more...
acuderm.com | Send Inquiry | Phone: +001-(800)-327-0015
FDA Registration: 1035236 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Punches (FDA Code: FCI), Cauteries, Cold Sterilization Solution, ...
Acuderm, Inc markets quality specialty medical products, disposable instruments and dermatology supplies. Our product line includes punches, curettes, acu excisor, needle, syringes, sutures, hyfrecato more...
R Medical Inc. | Address: 28835 N. Herky Drive, Unit 101, Lake Bluff, Illinois 60044, USA
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
Dental USA, Inc. | Address: 5005 Mccullom Lake Rd., Mchenry, Illinois 60050, USA
www.mydentalusa.com | Send Inquiry | Phone: +1-(815)-363-8003, 866-439-3400
FDA Registration: 3003969055
Products: Forceps (FDA Code: HTD), Suction Tubes, Spatulas, Calipers, Skin hooks, Surgical Scissors, ...
Dental USA, Inc. manufactures instruments for all branches of dental surgery. We offer a full line of stainless steel instruments. Our products include composite kit, endodontic, gingival grafting, im more...
www.mydentalusa.com | Send Inquiry | Phone: +1-(815)-363-8003, 866-439-3400
FDA Registration: 3003969055
Products: Forceps (FDA Code: HTD), Suction Tubes, Spatulas, Calipers, Skin hooks, Surgical Scissors, ...
Dental USA, Inc. manufactures instruments for all branches of dental surgery. We offer a full line of stainless steel instruments. Our products include composite kit, endodontic, gingival grafting, im more...
Zoll Dental | Address: 7450 North Natchez Ave., Niles, Illinois 60714, USA
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
E-Global Medical Equipment, L.L.C. | Address: 2F 500 Lincoln St., Allston, Massachusetts 02134, USA
Phone: +1-(866)-422-1845
Products: Trocars, Wheelchairs, Tissue Morcellator, Surgical Curette (FDA Code: FZS), Surgical Table Cushion (FDA Code: LWG), Wheelchair Cushions (FDA Code: IMP), ...
E-Global Medical Equipment, L.L.C. specializes in wheelchair seats & back cushions, surgical table cushions, suction irrigation units, morcellators, trocars, and surgical curettes. more...
Phone: +1-(866)-422-1845
Products: Trocars, Wheelchairs, Tissue Morcellator, Surgical Curette (FDA Code: FZS), Surgical Table Cushion (FDA Code: LWG), Wheelchair Cushions (FDA Code: IMP), ...
E-Global Medical Equipment, L.L.C. specializes in wheelchair seats & back cushions, surgical table cushions, suction irrigation units, morcellators, trocars, and surgical curettes. more...
Holmed Corporation | Address: 40 Norfolk Avenue, South Easton, Massachusetts 2375, USA
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
Gilbert Surgical Instruments | Address: 115 Harding Ave., Bellmawr, New Jersey 08301, USA
www.gilbertsurgical.com | Send Inquiry | Phone: +1-(856)-933-2770
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Uterine Sound Instruments, Suction Tubes, Endotracheal Tubes, Cricothyrotomy Kits (FDA Code: OGP), Ferguson-Frazier Suction Tubes, Gynaecological Instruments, Uterine Dilators, ...
Gilbert Surgical Instruments offers dental and medical equipments. Our premier evacuator/air filtration system with its distinctly quiet operation is suitable for electrosurgical or laser procedures. more...
www.gilbertsurgical.com | Send Inquiry | Phone: +1-(856)-933-2770
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Uterine Sound Instruments, Suction Tubes, Endotracheal Tubes, Cricothyrotomy Kits (FDA Code: OGP), Ferguson-Frazier Suction Tubes, Gynaecological Instruments, Uterine Dilators, ...
Gilbert Surgical Instruments offers dental and medical equipments. Our premier evacuator/air filtration system with its distinctly quiet operation is suitable for electrosurgical or laser procedures. more...
Buxton Biomedical, Inc. | Address: 15a Melaine Lane, Unit 7, East Hanover, New Jersey 07936, USA
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
Phone: +1-(913)-560-4848
FDA Registration: 2248030
Products: Splints, Forceps (FDA Code: HTD), Mallets, Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), ...
Buxton Biomedical, Inc. specializes in providing mallets, self-retaining retractors, bone tampers, calipers, cannulae, dissectors, forceps, goniometers, needle holders, splints, strippers and wire cut more...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Retractors, Scissors, Uterine Sound Instruments, Biopsy Punches (FDA Code: FCI), ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Retractors, Scissors, Uterine Sound Instruments, Biopsy Punches (FDA Code: FCI), ...
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...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Lacrimal Probes (FDA Code: HNL), Powered Surgical Laser Instrument (FDA Code: GEX), Contact Lens (FDA Code: HQD), Surgical Drapes & Packs (FDA Code: KKX), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Lacrimal Probes (FDA Code: HNL), Powered Surgical Laser Instrument (FDA Code: GEX), Contact Lens (FDA Code: HQD), Surgical Drapes & Packs (FDA Code: KKX), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
In'Tech Medical, Incorporated | Address: 2851, Lamb Place, Suite 15, Memphis, Tennessee 38118, USA
Phone: +1-(901)-375-1109
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Calipers (FDA Code: KTZ), Orthopedic Elevator (FDA Code: HTE), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
In'Tech Medical, Incorporated specializes in providing surgical curettes, calipers and orthopedic elevators. more...
Phone: +1-(901)-375-1109
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Calipers (FDA Code: KTZ), Orthopedic Elevator (FDA Code: HTE), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
In'Tech Medical, Incorporated specializes in providing surgical curettes, calipers and orthopedic elevators. more...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
Tedan Surgical Innovations, LLc | Address: 11333, Chimney Rock Road, Suite 180, Houston, Texas 77035, USA
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Small Depth Gauge (FDA Code: HTJ), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Small Depth Gauge (FDA Code: HTJ), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
Gynex Corporation | Address: 2789 - 152nd Avenue Ne, Redmond, Washington 98052, USA
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
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FDA Code / Regulation: FZS / 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.
