FDA 510(k) clearances — page 613
clearances on record, most recent first.
Clearances — page 613
61,201–61,300 of 176,637- K063718 — SFB AND CFB IMPLANTS - 5.0 PLATFORM
- K063762 — SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
- K063799 — STEAMPLUS STEAM INTEGRATOR
- K063803 — ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
- K061782 — GAMBRO POSICLEAR
- K062675 — GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
- K062755 — IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
- K063338 — HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
- K063509 — DEPUY PEAK FX HIP PLATE
- K063559 — ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
- K063709 — TS-BONE HIP TOOL
- K063761 — ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
- K061208 — LIFECELL DURAL SUBSTITUTE MATRIX
- K062289 — BONART ART-L3 LED CURING LIGHT
- K062318 — BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
- K062544 — AR1000 ULTRASONIC WOUND THERAPY SYSTEM
- K062896 — V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
- K062968 — LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES
- K063058 — ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
- K063843 — APEXNRG XFR
- K062787 — ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01
- K062905 — NIO FUSION 4MP; MDNC 4130
- K063140 — RAINBOW ADHESIVE CO-OXIMETRY SENSORS
- K063612 — MODIFICATION TO HEALTH BUDDY APPLIANCE
- K053218 — DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
- K062652 — INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
- K062788 — COLLIMATOR, MODEL M-38
- K063164 — VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
- K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
- K063276 — CLINITEK ADVANTUS, MODEL 1420
- K061676 — RIGIDOMETER, MODEL DIR-4U
- K062115 — CARBON DIOXIDE MONITOR, MODEL OLG-2800A
- K062355 — ENA CEM
- K062555 — EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
- K063009 — FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
- K063017 — AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
- K063074 — CANDELA 3630 LASER SYSTEM
- K063225 — METAIZEAU NAILING SYSTEM
- K063244 — ARC SURGICAL BONE REDUCTION SCREW
- K063643 — MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
- K060416 — OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
- K060852 — MOONCUP
- K061578 — SSP VERTEBRAL BODY REPLACEMENT
- K062265 — CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
- K062583 — ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
- K062785 — LTD POLYAXIAL FIXATION SYSTEM
- K062924 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
- K063143 — VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
- K063262 — AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
- K063382 — HDR CT COMPATIBLE SPLIT RING APPLICATOR
- K063459 — CRANEX NOVUS
- K063613 — MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K063628 — CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
- K060346 — ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM
- K060851 — SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
- K061350 — LITHODIAMOND ULTRA
- K061615 — INTERDRY TEXTILE WITH SILVER
- K061841 — QUANTA LITE INTRINSIC FACTOR ELISA
- K062151 — BOX PEEK VBR SYSTEM
- K062285 — VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
- K062314 — HORUS LASER KERATOME
- K062513 — APEX SPINE SYSTEM
- K062517 — ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
- K062533 — BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
- K062661 — AEQUALIS RESURFACING HEAD
- K062879 — TRAVERSE OCT SPINAL FIXATION SYSTEM
- K062880 — SUBDERMAL WIRE ELECTRODE, MODEL SWE
- K062940 — BONE INJECTION GUN (B.I.G.)
- K062965 — CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
- K063036 — OPUS HC482 DIRECT NASAL MASK
- K063057 — IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
- K063095 — HUMERUS LOCKING PLATING SYSTEM
- K063119 — LIFEPAK 20 DEFIBRILLATOR/ MONITOR
- K063127 — ENTEROCOCCUS FAECALIS PNA FISH
- K063160 — ALLERGEAZE PATCH TEST CHAMBERS
- K063166 — I.T.S. PELVIC RECONSTRUCTION SYSTEM
- K063224 — GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
- K063381 — CT COMPATIBLE F/S/D APPLICATORS
- K063395 — O&P BIVALVE CRANIAL MOLDING HELMET
- K063474 — ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
- K063484 — PATIENT DATA HANDLER & DEVICES (PDH&D)
- K063543 — COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
- K063551 — AEQUALIS HUMERAL PLATE
- K062383 — UNISYN HA PLASMA MODULAR HIP
- K062950 — POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
- K063055 — VS-800 VITAL SIGNS MONITOR
- K063182 — ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX
- K063230 — INTEGRA RADIONICS IMAGEFUSION 3
- K063424 — FILM DIGITZER, MODEL 2908 MAMMO PRO
- K063492 — VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
- K063493 — I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
- K063518 — HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
- K063547 — CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
- K063602 — AUTOPULSE RESUSCITATION SYSTEM MODEL100
- K063703 — CITRIC ACID 20% SOLUTION, MODEL 329
- K061227 — HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
- K061461 — MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
- K062277 — ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE
- K062353 — MOZAIK BONE REGENERATION MATRIX - PUTTY
Data sourced from openFDA. This site is unofficial and independent of the FDA.