FDA 510(k) clearances — page 541
clearances on record, most recent first.
Clearances — page 541
54,001–54,100 of 175,825- K082027 — FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
- K082321 — TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
- K082930 — CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
- K082988 — MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
- K083165 — PALOMAR ASPIRE LASER PLATFORM
- K083193 — REVAC AUTO RETRACTABLE SAFETY SYRINGE
- K083205 — NOBELACTIVE 8.5 MM & 18.0 MM
- K083309 — ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
- K083438 — BIFIX SE
- K083457 — TACTIPEN
- K083469 — METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
- K083475 — LUCENT MAGNUM
- K083503 — DRAD30003/RADREX-I
- K083740 — MAMMODIAGNOST VU
- K083827 — ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
- K083854 — CARDIAC TRIGGER, MODEL: CTM300
- K090016 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K090269 — AIRSTRIP OB
- K073121 — NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
- K082565 — MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
- K082845 — INFINITI VISION SYSTEM WITH OZIL IP
- K083047 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K083180 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
- K083268 — TORNIER, INC., INSITE SUTURE ANCHORS
- K083500 — MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
- K083531 — LIQUIBAND ULTIMA, MODEL LB0004
- K083655 — ELECSYS TOXO IGG CALCHECK
- K083742 — SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
- K083857 — LDR SPINE ROI-C IMPLANT
- K090085 — MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
- K090089 — BELMONT HYPERTHERMIA PUMP
- K090102 — NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
- K080436 — RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
- K080949 — KERATEC WOUND DRESSINGS
- K083121 — NEO MAPCATH SENSOR STYLET
- K083561 — NEOSS PROACTIVE IMPLANT
- K083734 — AXXENT SURFACE APPLICATOR, MODEL 710257
- K083828 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
- K083926 — CD4 COUNT
- K090103 — 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
- K090181 — WATERLASE MD
- K090220 — COLON VIEW, MODEL CSCV-001A
- K080210 — PRO QR ADVANCED FORMULA POWDER
- K081560 — VASCUTEK CANNULA GRAFT, MODEL CGS2008S
- K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
- K082137 — DLMS-ZIRBLOCKS
- K082428 — N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
- K083326 — FLUOROCORE 2
- K083468 — CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
- K083624 — POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
- K083737 — HALO ABLATION CATHETER
- K083824 — HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
- K090101 — EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
- K090255 — BLOOD TUBING SETS (STERILE FLUID PATH)
- K082371 — SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
- K082377 — TENSCARE ITOUCH MODEL(S) EASY AND PLUS
- K082690 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K082772 — STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
- K082918 — MASTERGRAFT RESORBABLE CERAMIC GRANULES
- K083006 — BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
- K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER
- K083140 — COMPEX SPORT PLUS
- K083458 — INTRAMEDULLARY FIXATION ROD (IFS)
- K073071 — EQ-PRC LC WARFARIN GENOTYPING KIT
- K073565 — STANDARD WHEELCHAIR PLATFORM
- K080987 — BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
- K081398 — ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
- K081463 — MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
- K081886 — KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
- K081888 — DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
- K081927 — RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
- K082019 — FREEDOM TOTAL KNEE SYSTEM
- K082055 — MODEL PC-860 FETAL DOPPLER
- K082268 — CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
- K082462 — GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
- K082556 — CLEARCORRECT
- K082727 — FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
- K082825 — ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
- K082869 — AWBAT-S, AWBAT-D, AWBAT-M
- K082873 — MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
- K082927 — BIOEMG III
- K082995 — SMART DILATOR
- K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT
- K083304 — TEMPOSIL 2
- K083330 — ECHOTIP ULTRA ULTRASOUND NEEDLE
- K083422 — 6F TAIGA GUIDING CATHETER
- K083442 — CORRIDOR FIXATION SYSTEM
- K083447 — MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
- K083706 — HI-TORQUE VERSACORE GUIDE WIRE
- K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
- K090158 — APLIO ARTIDA V2.0 SSH-880CV
- K090159 — INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
- K082833 — NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
- K082874 — BIODRIVE CANNULATED SCREW SYSTEM
- K082875 — PORTABLE X-RAY SYSTEM, MODEL DXR -1
- K083030 — TENS-EMS-14
- K083439 — SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
- K083684 — ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
- K090119 — SICAT IMPLANT
- K090122 — NUOVOGUARD
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