FDA 510(k) clearances — page 372
clearances on record, most recent first.
Clearances — page 372
37,101–37,200 of 175,770- K141505 — BASAL DIGITAL THERMOMETER
- K133322 — STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
- K133769 — 3B RESMART BPAP 25A, BMC RESMART BPAP 25A
- K140550 — ORTHOHUB EXTERNAL FIXATOR SOFTWARE
- K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
- K141553 — MEDELA THOPAZ+
- K142036 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
- K142044 — CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
- DEN120017 — Medtronic DUET External Drainage and Monitoring System
- K132772 — LUBRIGYN CREAM
- K133592 — NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM
- K133921 — PRECEPTIS TYMPANOSTOMY TUBE INSERTER
- K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE
- K140086 — PERSONAL KINETIGRAPH (PKG) SYSTEM
- K140149 — EPX-4440HD DIGITAL VIDEO PROCESSOR
- K140210 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720
- K140689 — IKNEE DISTAL FEMORAL CUTTING GUIDE
- K140944 — 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
- K140945 — COMPACTCATH INTERMITTENT URINARY CATHETER
- K140946 — NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
- K141065 — CONSTELLATION VISION SYSTEM
- K141083 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
- K141288 — VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE
- K141372 — MERCURY SPINAL SYSTEM
- K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
- K141480 — CVI42
- K141509 — ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
- K141597 — MUSTANG BALLOON DIALATION CATHETER
- K141642 — VAPRO INTERMITTENT CATHETER
- K142002 — BREAST SPEEDER CX, GRID HOLDER CX
- K142017 — X-PORTE ULTRASOUND SYSTEM
- K132326 — IONSIL GEL
- K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MX
- K133638 — GEKO
- K133706 — ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
- K140028 — GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
- K140600 — SB ANCHOR
- K140681 — BELTER INFRA-RED EAR THERMOMETER
- K141004 — INTRAOSSEOUS FIXATION SYSTEM
- K141127 — MEDLINE ANTI-EMBOLISM STOCKING
- K141215 — SURGISEAL TWIST TOPICAL SKIN ADHESIVE
- K141264 — TENSYN BAND, TENSYN FRACTURE PLATES
- K141357 — BARRX FLEX RFA ENERGY GENERATOR
- K141508 — ROMEO 2 PAD POSTERIOR AXIAL DEVICE
- K141521 — MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
- K141567 — IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
- K141585 — SMITH & NEPHEW DISPOSABLE FIN PUNCH
- K141930 — OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
- K142006 — SYMBIA 6.0
- K142121 — VALOR HINDFOOT FUSION NAIL SYSTEM
- K142148 — ORTHOHELIX STAPLE SYSTEM
- DEN140001 — ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
- K140270 — NEXUS MIDLINE CT CATHETER
- K140347 — ANKYLOS C/X IMPLANT SYSTEM
- K140507 — HIOSSEN PROSTHETIC SYSTEM
- K140537 — TENURE4G
- K140748 — ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
- K140878 — STRAUMANN BONE LEVEL TAPERED IMPLANT
- K140965 — MULTIPIEZO PRO, MULTIPIEZO
- K141308 — NUTRA LIGHT RED
- K141788 — OBSIDIAN MILLING BLOCKS
- DEN140016 — STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
- K131285 — SONOSENTRY
- K133952 — VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
- K140703 — OPA 30 SOLUTION
- K140723 — NOMAD MD 75K V HANDHELD X-RAY SYSTEM
- K141136 — LEICA FL800
- K141772 — IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
- K141979 — ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
- K141988 — M.U.S.T PEDICLE SCREW SYSTEM
- K133703 — PHYSIOGLOVE ET SYSTEM
- K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES
- K140585 — CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
- K141044 — M.U.S.T. EXTENSION
- K141352 — ENDOCYN ROOT CANAL IRRIGATION SOLUTION
- K141653 — BIOLOX DELTA CERAMIC OPTION HEADS
- K141769 — OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
- K142011 — SOLUTION SET/EXTENSION SET
- K132518 — NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
- K132049 — THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
- K133582 — HEMOSIL D-DIMER HS 500 CONTROL
- K133981 — AVACEN 100
- K140306 — CORMATRIX PROTECT ECM ENVELOPE
- K140308 — MASTERSURG / EXPERTSURG
- K140366 — ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
- K140919 — RESPICONNECT ADAPTER
- K140933 — ALIVECOR HEART MONITOR
- K140966 — VONFLEX S BITE
- K141090 — NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
- K141129 — EXACTECH CERVICAL SPACER SYSTEM
- K141735 — ARTHREX ANKLE FUSION PLATING SYSTEM
- K141951 — DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
- K130720 — SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
- K132633 — OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
- K133973 — TEMPUS PRO WITH ENHANCED FEATURES
- K140232 — SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
- K140508 — ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
- K140737 — STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
- K141141 — KIVA VCF TREATMENT SYSTEM
- K141153 — LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED
Data sourced from openFDA. This site is unofficial and independent of the FDA.