FDA 510(k) clearances — page 376
clearances on record, most recent first.
Clearances — page 376
37,501–37,600 of 175,770- K140316 — EXAMINATION GLOVES
- K140451 — KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
- K140459 — ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
- K140830 — EXPRT REVISION KNEE
- K140998 — PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
- K141301 — MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
- K141334 — REUSABLE GUIDE
- K141368 — NEUROPACE BURR HOLE COVER
- K141388 — SYSTEM CALIBRATER
- K141486 — MYLABSIX ULTRASOUND SYSTEM
- K141550 — INSTAFIX SHAPE MEMORY FIXATION SYSTEM
- K141554 — ESIE APPS SUITE
- K141558 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
- K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
- K131692 — BLOSSOM SALINE DELIVERY ASSIST DEVICE
- K132919 — GANTRY BEAM LINE
- K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT
- K133819 — VERADIUS
- K140101 — ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
- K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUP
- K140658 — THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
- K140765 — RANGE/MESA/DENALI SPINAL SYSTEM
- K140976 — ENADEN FLOW
- K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
- K134005 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K140409 — FLENTS PLASTIC EYE WASH CUP
- K140417 — DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
- K140513 — MERIT SAFETY INTRODUCER NEEDLE
- K140531 — BIOFOAM BONE WEDGE
- K140917 — INTRODUCER, MODEL ADELANTE MAGNUM
- K141245 — ETEX MIXING AND DELIVERY SYSTEM
- K141417 — CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
- K141444 — IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
- K132761 — WIRELESS THERMOMETER
- K133811 — RESTORIS POROUS PARTIAL KNEE SYSTEM
- K140144 — BENDA WEDGE
- K140643 — GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
- K140816 — POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
- K141102 — HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
- K141117 — EZ-IO INTRAOSSEOUS INFUSION SYSTEM
- K141151 — CT MIDLINE
- K141228 — AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
- K141273 — WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
- K141478 — ARTHREX FRACTURE PLATES AND SCREWS
- K141618 — ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
- K131601 — DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
- K132214 — ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
- K132778 — GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
- K133299 — ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
- K133648 — SYNGO, CT DUAL ENERGY
- K133784 — VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
- K140324 — RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
- K140785 — PULSE OXIMETER
- K141051 — VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
- K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- K131923 — NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
- K132543 — INFANT INCUBATOR
- K132881 — Z5C
- K132987 — COBRA FUNDUS CAMERA
- K133114 — MICROPUNCTURE INTRODUCER SET
- K133528 — H&H EMERGENCY CRICOTHYROTOMY KIT
- K133689 — POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
- K133835 — ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
- K140141 — LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
- K140241 — EDWARDS TRANSFEMORAL BALLOON CATHETER
- K140333 — ASCEND
- K140641 — VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
- K140652 — POROUS COATED COMPREHENSIVE FRACTURE STEMS
- K140869 — DCAS I
- K140902 — E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
- K140962 — NORMED VARIO SUBTALAR SCREW
- K141134 — POD SYSTEM
- K132384 — U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
- K133110 — EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
- K133861 — FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM
- K140055 — ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
- K140121 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
- K140162 — AP EXPANDABLE XLIF SYSTEM
- K140260 — SKYHAWK LATERAL PLATE SYSTEM
- K140351 — ARROW GPSCATH BALLOON DILATATION CATHETER
- K140512 — UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
- K140572 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K140596 — NAVIO
- K140601 — FLOW-NAIL
- K140685 — ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
- K140849 — ISOSEED
- K140909 — MCKESSON RADIOLOGY
- K141369 — VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
- K141392 — SPHYGMOMANOMETER
- K141452 — LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
- K141485 — ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
- K141499 — X-REPAIRSL
- K141556 — AVREO INTERWORKS SYSTEM
- K141620 — RS80A DIAGNOSTIC ULTRASOUND SYSTEM
- K132036 — HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
- K132903 — DRE VENTURA
- K133288 — CASPIAN OCT SPINAL SYSTEM
- K133693 — DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
- K133916 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
Data sourced from openFDA. This site is unofficial and independent of the FDA.