FDA 510(k) clearances — page 546
clearances on record, most recent first.
Clearances — page 546
54,501–54,600 of 175,825- K082985 — A-DEC 334/335 DELIVERY SYSTEM
- K083392 — NOVATION 12/14 CEMENTED FEMORAL STEMS
- K083498 — PHILIPS MODEL MX 16 SLICE CT SYSTEM
- K083610 — FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
- K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
- K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
- K082210 — TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
- K082278 — MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
- K082424 — UNITED U2 TOTAL KNEE SYSTEM
- K082451 — STRYKER VIDEOSCOPE
- K082724 — NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
- K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
- K083070 — TOGGLELOC SYSTEM
- K083137 — NEURO III-SV
- K083164 — SYSTEM-ARMS, MODELS 390, X60
- K083171 — INTROL CF PANEL I CONTROL, MODEL: G106
- K083272 — SKINCLEAR Q-SWITCHED ND:YAG LASER
- K083538 — NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
- K083555 — PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
- K073417 — EMBOZENE MICROSPHERES
- K080542 — DISTRAX
- K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
- K082355 — VISIONSENSE STEREOSCOPIC VISION SYSTEM
- K082460 — CENEFOM PVA SURGICAL SPEAR
- K082509 — EOS SPINAL SYSTEM
- K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152
- K082755 — SEDAT FLAMINGO
- K083093 — CHEETAH RELIANT
- K083129 — SHARPS COMPLIANCE CONTAINER
- K083202 — COMBOCARE 2000
- K083211 — AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
- K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
- K083402 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
- K083535 — HEARTRAK SMART ECAT
- K072831 — FROG
- K081095 — PROLITE III TOWER AND PR AND HR HANDPIECE
- K081852 — TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
- K082090 — 9131 DEFIBRILLATION ELECTRODES
- K082248 — STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
- K082269 — VISAGE PACS, VERSION 6.0/CS 3.1
- K082382 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
- K082416 — IBA PROTON THERAPY SYSTEM- PROTEUS 235
- K082603 — TRIMIRA OCS 3000
- K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT
- K082795 — SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
- K082932 — CPS AIM SL SLITTABLE INNER CATHETER
- K082970 — MARVEL WHEELCHAIR, MODEL EDCAL01
- K083044 — HUBANG, MODEL HBL13/HBG12-S
- K083282 — MODEL TSX-301B AQUILION CT SYSTEM
- K083370 — D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
- K083379 — CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
- K083440 — PRIMATRIX DERMAL REPAIR SCAFFOLD
- K083504 — GE DISCOVERY NM/CT 570C
- K083505 — DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K070541 — IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
- K081824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
- K081825 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
- K081972 — BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
- K082008 — BIONET BM3PLUS PATIENT MONITOR
- K082385 — CHAPERON GUIDING CATHETER
- K082559 — SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
- K082671 — HERCULITE ULTRA
- K082744 — BEAUTIBOND
- K082769 — MESA AND RANGE SPINAL SYSTEMS
- K082770 — ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
- K082914 — CLAMPFIX
- K083353 — CAPSURE(R) PS SYSTEM
- K083364 — 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
- K083400 — CUSTOM COMFORT NIGHTGUARD
- K083560 — EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
- K071474 — DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
- K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
- K080810 — EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
- K082448 — DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
- K082561 — SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
- K082902 — RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
- K083299 — TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
- K083306 — MODIFICATION TO ARTHROCARE ARTHROWANDS
- K083308 — PASS LP SPINAL SYSTEM
- K071573 — RUGALIFT, MODEL# V.2.1
- K073681 — NANOBEAM 940, MODEL 940-900-02
- K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
- K080428 — ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
- K081645 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
- K081828 — ZOLL R SERIES BLS DEFIBRILLATOR
- K082297 — BUSSE SURGICAL DRAPE
- K082302 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
- K082308 — MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K082672 — NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
- K082700 — TEMPORARY COLD.V AND SELF-CURE DENTINE
- K082922 — FREEWAY AND RAILRUNNER GUIDEWIRES
- K083013 — PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
- K083472 — MEDEGEN PRESSURE RATED EXTENSION SETS
- K080499 — MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
- K082384 — HAV-LOK BUNION CORRECTION SYSTEM
- K082574 — MAXTORQUE MINI CANNULATED SCREW SYSTEM
- K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE
- K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY
- K080558 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
- K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
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