FDA 510(k) clearances — page 380
clearances on record, most recent first.
Clearances — page 380
37,901–38,000 of 176,542- 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
- K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
- K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD
- K130631 — BUZZY
- K133685 — 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K140392 — 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
- K140476 — ARTHREX FIBERTAK SUTURE ANCHOR
- K140782 — ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
- K141128 — FINGERTIP PULSE OXIMETER
- K141517 — ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
- K141734 — ZIMMER PERIARTICULAR LOCKING SYSTEM
- K141956 — FIBERGRAFT BG MORSELS
- K131407 — BAHADIR STERILIZATION TRAYS
- K133255 — ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS
- K133358 — NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
- K133562 — CATARHEX 3
- K134014 — TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
- K140988 — POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
- K141077 — DA VINCI FIREFLY IMAGING SYSTEM
- K141225 — ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD
- K142021 — Elecsys Estradiol III CalSet
- K142116 — LLD EZ
- K133945 — CUTERA PICOSECOND LASER SYSTEM
- K141983 — NEUROBLATE SYSTEM
- K121886 — SAVINA 300 SAVINA 300, COUNTRY VARIANTS
- K133325 — BLUE NITRILE POWDER FREE EXAM GLOVES
- K133712 — EMBRYOVIEWER SOFTWARE
- K133751 — DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
- K140381 — SENSILIGHT/ SENSILIGHT PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.