FDA 510(k) clearances — page 422
clearances on record, most recent first.
Clearances — page 422
42,101–42,200 of 175,770- K122768 — GENESIS
- K123098 — XGEO GC80
- K123163 — NEUROPACE BURR HOLE COVER MODEL 8110
- K123231 — CALIBER SPACERS
- K123299 — MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
- K123300 — BD PEN NEEDLE
- K123328 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
- K123813 — VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
- K123828 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
- K123920 — SYNGO.VIA
- K102689 — CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
- K121098 — HERO I DENTAL IMPLANT SYSTEM
- K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
- K121606 — RESORB-X G
- K121929 — ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
- K122132 — AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
- K122408 — POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
- K122585 — CRUX VENA CAVA FILTER SYSTEM
- K122788 — TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
- K122951 — XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
- K123110 — PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
- K123417 — BRIVO MR355, OPTIMA MR360
- K123612 — FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
- K123734 — BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
- K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
- K124003 — MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE
- K113246 — OCS-B
- K121392 — NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE
- K121570 — AURIGA QI
- K123038 — SWISS LITHOBREAKER
- K123264 — DK-PTCA BALLOON CATHETER
- K123274 — PROGASTRO SSCS ASSAY
- K123609 — MERIT HYDROPHILIC GUIDE WIRE
- K123671 — WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
- K123838 — PRO HMPV+ ASSAY
- K123922 — SYNGO DYNAMICS
- K122873 — VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
- K123004 — MIRA LASERS
- K123408 — ERGO IMAGING SYSTEM
- K123535 — ILAB ULTRASOUND IMAGING SYSTEM
- K123788 — INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
- K123878 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
- DEN130003 — XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
- K121706 — FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
- K122708 — REMESENSE FOR SENSITIVE TEETH
- K122870 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K123311 — QXMEDICAL ACCESS & SUPPORT CATHETER
- K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
- K123752 — ACCULIF TL AND PL CAGE
- K123898 — VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
- K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K120949 — INFRASCANNER
- K121254 — CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
- K121313 — MTF NEW BONE VOID FILLER
- K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
- K122572 — ICAM FUNDUS CAMERA
- K122576 — TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
- K122685 — ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
- K122866 — VIVIX-S WITH VXVUE
- K122878 — HD-IVUS ULTRASOUND IMAGING SYSTEM
- K123048 — PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
- K123270 — POWEREASE SYSTEM
- K123302 — IB CLINIC
- K123324 — SELECTRA 7F CATHETERS
- K123327 — 1.5T GEM RT OPEN ARRAY
- K123414 — SPECBOARD JR.
- K123644 — VIZION + DR
- K123839 — WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200
- K121206 — DETECT
- K121959 — EVIS EXERA III VIDEO SYSTEM
- K122077 — MANOMETER
- K122383 — EM3 AEM MONITOR AEM CONNECTORS
- K122391 — MEDTRONIC XOMED, INC.
- K122687 — BLOOD CULTURE HOLDER
- K122771 — SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K122922 — E-BEAM ND: YAG LASER
- K123201 — AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
- K123223 — EC SINGLE USE, POLYPECTOMY SNARE
- K123342 — OPTETRAK LOGIC CRC TIBIAL INSERT
- K123396 — I.FLEX BY TCS
- K123438 — XENX STONE MANAGEMENT DEVICE
- K123516 — CRYO-TOUCH IV
- K123845 — ME
- K123849 — NEW COMFORT-FIT DENTAL GUARD
- K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
- K123911 — SENOMARK ULTRA BREAST TISSUE MARKER
- K121399 — LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
- K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
- K122336 — Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
- K122357 — MERITS MODEL P322FWD POWERED WHEELCHAIR
- K122704 — BEST LOCALIZATION NEEDLE WITH I-125 SEED
- K122914 — AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
- K123213 — BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
- K123441 — STRYKER CROSSFLOW ARTHROSCOPY PUMP
- K123781 — TRANSTEK GLASS BODY FAT ANALYZER
- K123798 — LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
- K123863 — UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
- K121261 — ASAP MUITISCOPE
- K121621 — SOLOCEM
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