FDA 510(k) clearances — page 418
clearances on record, most recent first.
Clearances — page 418
41,701–41,800 of 175,770- K123725 — FASTPACK CONTROL KIT
- K123776 — POLARIS 100/200
- K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
- K123998 — QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
- K130034 — UNI-PICC
- K130128 — TRINITY ACETABULAR SYSTEM
- K121511 — MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
- K122476 — LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
- K123081 — BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
- K123136 — GENESIS HEALTH RECORD SYSTEM, (GHRS)
- K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
- K123350 — ECLIPSE SOFT TISSUE FASTENER
- K123395 — NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
- K123411 — LITTLE ANGELS SWADDLING BLANKET
- K123554 — SHUNTCHECK
- K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
- K123694 — SAM JUNCTIONAL TOURNIQUET
- K124007 — SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
- K124039 — HERO GRAFT
- K130283 — EVRF SYSTEM
- K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
- K122513 — CLEARED UNDER GRAFTON II EDBM
- K122847 — KANGAROO NASAL MASK
- K123373 — NAUTILUS SPINAL SYSTEM
- K113717 — ULTRASONIC SCALER
- K120740 — COLS® FIXATION SYSTEM
- K121488 — JMS SAFE WING CATH (SWC)
- K121769 — DENTOCORE / DENTOCORE BODY
- K122986 — VIDAS LYME IGG
- K123356 — FORTIVA PORCINE DERMIS
- K123449 — BIOMONDE LARVAE
- K123464 — CALLISTO EYE
- K123472 — CIMVA UNIVERSAL
- K123819 — MULTIPLE NAME
- K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
- K123914 — RESTORELLE Y CONTOUR
- K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
- K123993 — SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
- K130116 — SUPERIOR LATERAL VARIAX CLAVICLE PLATE
- K123059 — INBONE ( I AND II) TOTAL ANKLE SYSTEMS
- K123188 — DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC
- K123392 — AVENIR MULLER STEM
- K123717 — UCENTUM
- K123818 — URSA ANGIOGRAPHIC CATHETER
- K123889 — ACLEARA, THERACLEAR
- K123893 — CURA COLLIMATOR
- K130307 — ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
- K120001 — UNIGOLD GIARDIA
- K121430 — EVOLUTION BILIARY STENT SYSTEM
- K122016 — REXTAR, REXTAR LCD
- K122590 — RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
- K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
- K123220 — VERTEX THERMOSENS RIGID
- K123365 — OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
- K123426 — MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
- K123602 — TM ARDIS INTERBODY SYSTEM INSERTER
- K123606 — CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE
- K123675 — RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
- K123749 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
- K123761 — VITA ENAMIC STAINS
- K123780 — TRANSTEK BLOOD PRESSURE MONITOR
- K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
- K123812 — COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
- K123924 — DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
- K130155 — MUSE CARDIOLOGY INFORMATION SYSTEM
- K130162 — LIQUID ASSAYED MULTIQUAL PREMIUM
- K130243 — ILAB ULTRASOUND IMAGING SYSTEM
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
- K130262 — MAGNETOM ESSENZA WITH SYNGO MR D14
- K121901 — TI-MAX Z45
- K121969 — U-RIGHT COMPRESSOR NEBULIZER
- K121999 — GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
- K122647 — SYNTHES PATIENT SPECIFIC PLATE
- K122872 — INTERVERTEBRAL BODY FUSION DEVICE
- K122936 — ANKLE TRAUMA SYSTEM
- K123195 — CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
- K123289 — DURABLUE STERILIZATION WRAP
- K123348 — CLEAR ALIGNER ADHESIVE
- K123497 — FACET SCREW SYSTEM
- K123679 — 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
- K123707 — ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
- K123738 — MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
- K123751 — LOFRIC SENSE
- K123869 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
- K123959 — CIRCUFLOW 5150
- K123965 — COBAS INTEGRA BILIRUBIN DIRECT GEN.2
- K130078 — QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K130131 — EDRAIN CHEST DRAINAGE SYSTEM
- K120592 — DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
- K121360 — BIODESIGN ENT REPAIR GRAFT
- K122661 — VITAL 5 RELEAF CATHETER
- K123002 — VITAL SYNC SYSTEM
- K123361 — ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
- K123442 — XOFT AXXENT CERVICAL APPLICATORS
- K123501 — OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
- K123672 — INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
- K123682 — INMODE HAIR REMOVAL (HR) DEVICE
- K123816 — DIGITAL ELECTROCARDIOGRAPHS
- K123979 — QUATTRO AIR
- K130061 — PICCOLO COMPOSITE PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.