FDA 510(k) clearances — page 549
clearances on record, most recent first.
Clearances — page 549
54,801–54,900 of 175,825- K082335 — SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
- K082412 — VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
- K082457 — MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
- K082463 — PROGENIX
- K082606 — COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
- K082624 — SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
- K082641 — FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
- K082876 — BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
- K081011 — AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
- K081062 — AIRSONNETT AIRSHOWER AIR 3
- K081128 — MOLAR IMPLANT
- K081420 — VANISHPOINT I.V. CATHETER
- K081570 — DPL THERAPY SYSTEM
- K081725 — ENTERAL PUMP SET, MODEL 20-1010
- K081806 — IDI IMPLANT SYSTEM
- K082056 — ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
- K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
- K082072 — SYNTHES (USA) 3.5MM LCP HOOK PLATE
- K082113 — NOX T3, NOXTURNAL (PC APPLICATION)
- K082243 — PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
- K082266 — DIGITAL CLINICAL THERMOMETER MODEL V9XX
- K082282 — HEALIX TI ANCHOR
- K082369 — CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
- K082427 — SYNGO MR B17
- K082454 — MICROMYST APPLICATOR, MODEL 20-5000
- K082475 — REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- K082512 — INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
- K082619 — SILS PORT, MODELS SILSPT5, SILSPT12
- K082627 — MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL
- K082642 — ONCENTRA RT VIEWER 1.0
- K082688 — PRO HMPV+ ASSAY
- K082974 — MYSTIQUE MB CERAMIC BRACKETS
- K083141 — SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K083148 — TELECTRODE WET GEL ECG ELECTRODE
- K083160 — 1.5T ATLAS SPEEDER HEAD-NECK COIL
- K080613 — CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
- K081088 — MYRAY SKYVIEW
- K081456 — OLYMPUS CHF TYPE V
- K081773 — OSV II
- K081979 — ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
- K082261 — DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
- K082706 — INFINITT CARDIOLOGY PACS
- K082987 — HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
- K083033 — VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
- K083083 — AGILIS NXT STEERABLE INTRODUCER
- K080217 — COMPONENT NEUROMONITORING SYSTEM
- K081026 — BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
- K081145 — MODIFICATION TO 4CIS VANE SPINE SYSTEM
- K081858 — RETCAM 3 OPHTHALMIC IMAGING SYSTEM
- K082101 — LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
- K082252 — INDEPENDENCE SPACER
- K082320 — DARCO SMALL SCREW
- K082720 — TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
- K082980 — ARTHROCARE ARTHROWANDS
- K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
- K083147 — DISCOVERY MR450
- K082050 — LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
- K082078 — ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
- K082215 — OSTEORAPTOR SUTURE ANCHOR
- K082646 — OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
- K082933 — PASSEO-35 PTA CATHETER
- K072752 — BP LIMBO XL, BPTANGO XL, BP SALSA XL
- K080057 — IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
- K080254 — SCANSCOPE XT SYSTEM
- K080527 — TWINGUARD WITH CAPNOGRAPH ACCESSORY
- K080979 — STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
- K081312 — ARAGON ONESHOT SYSTEM
- K081741 — NEUROLINK IP, MODEL PK1113
- K082290 — NEURON DELIVERY CATHETER 070
- K082305 — G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
- K082410 — MASTER3DS
- K082821 — SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
- K082942 — MODFICATION TO: EXPEDIUM SPINE SYSTEM
- K082945 — STARLIGHT
- K082966 — PB 540 VENTILATOR
- K082981 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
- K083095 — SONIXTOUCH ULTRASOUND SYSTEM
- K083135 — MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
- K081724 — HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
- K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
- K082171 — GRADIA CORE
- K082178 — TEPHAFLEX ABSORBABLE SUTURE
- K082241 — THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
- K082530 — APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
- K082667 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
- K082717 — AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
- K082906 — UNITY BETA ANCHOR SYSTEM
- K083066 — CHROMOPHARE E 778 AND E 558
- K073307 — MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
- K082163 — FLOWMEDICA BENEPHIT INFUSION SYSTEMS
- K082198 — DURASHIELD PLUS
- K082267 — PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
- K082357 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).
- K082847 — PINNACLE ROII INTRODUCER SHEATH
- K083021 — APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K082183 — PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
- K082209 — DEVILBISS DV5M SMARTLINK SYSTEM
- K082314 — BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
- K082414 — OPTIFLUX F250NR, MODEL 0500325E
- K082595 — MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
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