FDA 510(k) clearances — page 713
clearances on record, most recent first.
Clearances — page 713
71,201–71,300 of 175,825- K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
- K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS
- K032110 — PROCLASS PRESS FIT HIP STEM
- K032169 — CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
- K032187 — ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
- K032299 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
- K032380 — WAGNER CONE PROSTHESIS
- K032510 — ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
- K032778 — LARGE VOLUME FLUID RESERVOIR
- K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
- K030145 — GALIX WINTER
- K030180 — CRESCENT TINNITUS RETAINING SOUND GENERATOR
- K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
- K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000
- K030815 — AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
- K030821 — SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
- K030832 — PRIMOSPLINT SYSTEM
- K030836 — D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
- K031099 — SORB+HISORB+CARTRIDGE
- K031351 — FLEX-NECK PD CATHETER, INFANT
- K031855 — SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
- K031902 — ONLINE TDM CARBAMAZEPINE
- K031925 — PROCEED TRILAMINATE SURGICAL MESH
- K031967 — TSRH SPINAL SYSTEM
- K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE
- K032137 — PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K032267 — R&D DESIGNATION AP-052-5
- K032269 — SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
- K032495 — THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM
- K032567 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
- K032578 — TSRH SPINAL SYSTEM
- K032582 — UNITY NETWORK PATIENT DATA SERVER
- K032584 — RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
- K032611 — LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
- K032760 — APAX PACS SYSTEM
- K030504 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
- K030719 — PENTACAM SCHEIMPFLUG CAMERA
- K030846 — CANDELA SMOOTHBEAM LASER SYSTEM
- K031499 — DIOBEAM 830
- K031593 — SOPRO 61D
- K031632 — OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
- K031933 — MEDLINE REUSABLE SURGICAL GOWNS (100X)
- K031948 — PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
- K032165 — VINTAGE AL
- K032529 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310
- K032542 — MODIFICATION TO CONTOUR SE MICROSPHERES
- K032569 — SHORT INTRODUCER SHEATH
- K032615 — ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
- K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
- K032749 — BEDSIDE MONITOR, MODEL OPV-1500
- K023837 — LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
- K024148 — SALINUM, ORCLAIR
- K030614 — 3I DENTAL IMPLANTS
- K031337 — ACUMEN SURGICAL NAVIGATION SYSTEM
- K031932 — FLUORIDE VARNISH
- K031972 — ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
- K031983 — INOVO, INC, ECONOMIZER CONSERVING REGULATOR
- K032054 — RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
- K032212 — KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
- K032431 — PRISMA M60/M100 SETS
- K032518 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
- K032566 — NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
- K030466 — HANDYDOP
- K030522 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
- K030564 — THERMOSKIN CONDUCTIVE PADS
- K030961 — MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
- K031359 — S-MONOVETTE EDTA K2-GEL
- K032033 — CD HORIZON SPINAL SYSTEM
- K032150 — SAFETY-MULTIFLY
- K032163 — DURACON TOTAL KNEE SYSTEM
- K032229 — QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
- K032393 — INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
- K032538 — 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
- K032541 — POLESTAR N-20
- K032552 — ACCU-CHEK ADVANTAGE SYSTEM
- K032588 — MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
- K032618 — 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
- K032652 — RS-4I MUSCLE STIMULATOR FAMILY
- K032653 — E275
- K032754 — VORTEX MP
- K022156 — LATEX ULTRASONIC PROBE COVER
- K022258 — B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
- K031721 — COMPOSITE RESTORATION MATERIAL
- K031801 — PANTOS, MODELS: PANTOS 16, AND PANTOS DG
- K031899 — QUICKVUE INFLUENZA A+B TEST
- K031951 — TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
- K031985 — SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
- K032153 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
- K032418 — DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
- K032561 — RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
- K032638 — DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY
- K032640 — FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
- K032658 — MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
- K030734 — PATHWAY ACCESS SHEATH CATHETER
- K030790 — OSTEOMED ALVEOLAR DISTRACTION SYSTEM
- K031287 — STERI-DRAPE SURGICAL DRAPES
- K031563 — BINDAZYME CLQ CIC EIA KIT
- K031659 — UNIVERSAL NEURO SYSTEM
- K031800 — SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
- K031815 — INTERA-SENSATION FAMILY
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