FDA 510(k) clearances — page 516
clearances on record, most recent first.
Clearances — page 516
51,501–51,600 of 176,542- K100339 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100345 — SYSTEMS INTEGRATION MODEL: ENDOALPHA
- K100350 — HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
- K091120 — MEDPOR CONTAIN IMPLANT
- K091564 — NBM-200MP PULSE OXIMETRY DEVICE
- K092848 — ELECSYS TROPONIN T CALCHECK 5
- K093115 — KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
- K093492 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
- K093983 — SMPLE PLATE AND SCREWS
- K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT
- K100083 — ESTHETICA
- K100202 — SLIT LAMP BO 900, BQ 900, BP900
- K100293 — ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
- K100457 — OPUS SPEEDSCREW SYSTEM
- K091631 — ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW
- K091741 — TINA-QUANT CERULOPLASMIN
- K092149 — BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215
- K092363 — SOFTVIEW, MODEL 2.01
- K092428 — BIO-OSS COLLAGEN
- K092565 — DIGITAL RETINAL CAMERA CX-1
- K092699 — NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
- K092944 — DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
- K093419 — IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS
- K093460 — COAGUCHEK XS PRO SYSTEM
- K093603 — STORM-BASE 2.0
- K093669 — SEC IBF CAGE
- K093670 — MODIFICATION TO: OASYS SYSTEM
- K093792 — LED LIGHT SOURCE
- K093912 — ARTHREX TIBIAL GRAFTBOLT
- K093957 — ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- K094028 — CP-FIBER (ORTHOFIBER)
- K100226 — WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
- K092558 — WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
- K093676 — OMNITECH LARGE, TRIMED COMPRESSION SCREW
- K093934 — GORE HYBRID VASCULAR GRAFT
- K093965 — ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS
- K100035 — MODEL VISULAS 532S LASER WITH THE VITE OPTION
- K100395 — HARMONY VLED SURGICAL LIGHTNING SYSTEM
- K100520 — NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
- K100532 — VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
- K100572 — VERSACLOSE, MODEL VC-200-01
- K092308 — POLESTAR, MODEL N-30
- K092352 — SCUBA BILIARY STENT SYSTEM
- K092427 — SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
- K092825 — APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
- K093044 — OASIS MRI SYSTEM
- K093066 — I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
- K093485 — VESISCAN
- K093888 — COOPDECH ENDOBRONCHIAL BLOCKER TUBE
- K100351 — NEUROSCOUT STEERABLE GUIDEWIRE
- K100474 — QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
- K100484 — IMPIX MANTA CERVICAL INTERBODY DEVICE
- K100485 — GYNECARE TVT EXACT CONTINENCE SYSTEM
- K100490 — LITEPAC, MODEL 682
- K091555 — MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
- K092726 — MESH GPS - LARGE, SMALL, SM, SM SMALL
- K093122 — MBCP+
- K093232 — OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
- K091722 — COAXIAL APPLICATOR SYSTEM
- K092265 — VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
- K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY
- K092784 — C. ALBICANS/C. GLABRATA PNA FISH
- K092922 — SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER
- K092950 — SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
- K093213 — GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
- K093556 — VCARE DX
- K093571 — ZR DENTAL BLOCK
- K093577 — LIQUICHEK OPIATE CONTROL
- K093795 — ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010
- K093815 — LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
- K093852 — EZLASE 3 LASER SYSTEM
- K093881 — TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
- K093930 — DIDGET WORLD REPORTS
- K100552 — RAYSTATION VERSION 1.0
- K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
- K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
- K092474 — PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
- K092847 — 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
- K092852 — SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K092886 — WELL LEAD ENDOBRONCHIAL TUBES
- K092980 — PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
- K093787 — IGUIDE CAPPA
- K093864 — AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
- K093936 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K100094 — CARESTREAM IMAGE SUITE
- K100352 — DIAGNOSOFT HARP MODEL 2.06
- K083803 — FIXIT HEADREST CLAMP SYSTEM
- K091520 — IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
- K091975 — INTEGRATED LABORATORY AUTOMATION SOLUTION
- K092089 — CLARUJUST
- K092141 — VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
- K092383 — BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300
- K092409 — HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
- K092414 — CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
- K092545 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003
- K092786 — INBODY, MODELS: 270, R20, R20B
- K092908 — NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO
- K092930 — NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
- K093124 — PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03
- K093384 — MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
Data sourced from openFDA. This site is unofficial and independent of the FDA.