FDA 510(k) clearances — page 453
clearances on record, most recent first.
Clearances — page 453
45,201–45,300 of 175,770- K113644 — PILOT TUBE REPAIR KIT
- K120073 — INFX-8000V WITH
- K120075 — AM-6000 ANESTHESIA MACHINE
- K111337 — TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
- K111634 — XENON(TM) PEDICLE SCREW SYSTEM
- K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
- K112251 — SWISSMEDA DENTAL PLANNING SYSTEM
- K112312 — THERATRODE
- K112576 — ENDOCHOICE WATER BOTTLE CAP SYSTEM
- K112981 — SUN 125C IONIZATION CHAMBER
- K113632 — DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K113663 — SONIXTABLET ULTRASOUND SCANNER
- K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
- K113855 — PANORAD, PANORAD SL
- K110923 — COBAS 4800 CT / NG TEST
- K111877 — EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
- K112705 — AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
- K112858 — GENESIS TOUCH SYSTEM
- K112904 — STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
- K113059 — CONTIPLEX FX
- K113154 — IVAS BALLOON CATHETER
- K113167 — MTF NEW BONE VOILD FILLER
- K113858 — MEGABEAM ENDO-ENT PROBE
- K110534 — RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
- K111971 — SYNDE-LOCK SYNDESMOSIS REPAIR KIT
- K112574 — PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
- K112808 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
- K113092 — ZIMMER CONTOUR PROVISIONAL COPING
- K113146 — PCXX VARNISH
- K113301 — CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
- K113661 — LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
- DEN120008 — STRATIFY JCV(TM) ANTIBODY
- K103697 — TORQTECH
- K110406 — CELLTRACKS AUTOPREP SYSTEM
- K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
- K110896 — RELIANCE SPINAL SCREW SYSTEM
- K111202 — SURGICAL TISSUE MANAGEMENT SYSTEM
- K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
- K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
- K112662 — MICROFRANCE(R) WORMALD VASCULAR CLAMP
- K112725 — LIAISON 25 OH VITAMIN D TOTAL ASSAY
- K112918 — DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
- K112934 — NEUROTECH RECOVERY
- K112936 — SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
- K113132 — DISPOSABLE HEMOSTATIC Y-CONNECTORS
- K113294 — SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
- K113302 — NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
- K113480 — SPECTRA OPTIA APHERESIS SYSTEM
- K113509 — LEXUS ANTERIOR CERVICAL PLATE SYSTEM
- K113527 — OPTICAGE INTERBODY FUSION DEVICE
- K113645 — REGENEROSS ALLOGRAFT PLUS MINERLIZED
- K113709 — MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
- K113769 — GPSCATH BALLON DILATATION CATHETER
- K113800 — QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
- K111157 — CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
- K111681 — HISTOBRUSH
- K111719 — OASYS SPINAL SYSTEM
- K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP
- K112348 — RS-4I MUSCLE STIMULATOR
- K112868 — DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
- K113083 — TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
- K113173 — NANOVIS SPINAL SYSTEM
- K113792 — MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
- K120010 — CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
- K110017 — AG-608N BLOOD GLUCOSE MONITORING SYSTEM
- K111221 — MISSION U500 URINE ANALYZER
- K111286 — QUASAR CALYPSO
- K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
- K111494 — HANDHELD PULSE OXIMETER
- K112612 — POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
- K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITOR
- K113773 — ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
- K112441 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
- K112716 — OSTEON II
- K112814 — CUFFINK
- K113098 — AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
- K113101 — EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
- K113248 — AERODR SYSTEM WITH P-21
- K113252 — PEEK PREVAIL CERVICAL INTERBODY DEVICE
- K113329 — K2M, PYRENEES CERVICAL PLATE SYSTEM
- K113366 — LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
- K113497 — HYPERION
- K113730 — PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
- K110083 — V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
- K110305 — CRY-ACTRACKERCAM
- K110480 — PDE PHOTODYNAMIC EYE
- K111162 — SLIM ONEBODY SYSTEM
- K111381 — MEDI-SIS SYRINGE INFUSION SYSTEM
- K111788 — ENDOEYE HD II
- K112013 — EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
- K112114 — MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
- K112189 — THERMO PAL INFRARED EAR THERMOMETER
- K112417 — VARIOUS
- K112677 — THE VENOUS ASSIST SYSTEM
- K112707 — GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
- K112727 — MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
- K112730 — ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
- K112852 — BABI PLUS NEONATAL RESUSCITATION BAG
- K113086 — ACQA
- K113093 — VANTAGE TITAN 3T
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