FDA 510(k) clearances — page 679
clearances on record, most recent first.
Clearances — page 679
67,801–67,900 of 176,637- K043227 — PERIARTICULAR LOCKING PLATES, 2358 SERIES
- K043287 — PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
- K043298 — BLUE ORTHOCORD SUTURE
- K043299 — MEDLEY PCA MODULE, MODEL 8120
- K041477 — PATHFINDER
- K042318 — AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
- K042413 — ACS MODEL NCP-2
- K042454 — STRYKER CASSETTE PUMP
- K042588 — CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
- K042689 — NICHOLS ADVANTAGE CORTISOL
- K042838 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II
- K043030 — MAGNETOM C! MR SYSTEM
- K043041 — AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
- K043070 — LIQUID STABLE HBA1C CONTROL
- K043103 — VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
- K043110 — MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
- K043117 — BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER
- K043155 — STARION UNIVERSAL POWER SUPPLY (UPS)
- K043243 — PRIMUS STENT AND DELIVERY SYSTEM
- K043275 — OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
- K041294 — BIOZDX HEMODYNAMIC MONITOR
- K042574 — ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
- K042629 — VARELISA SM ANTIBODIES, MODEL 18296
- K042664 — LPS UPPER EXTREMITY
- K042931 — TUF LINK SILICONE RELINER
- K043079 — BICONTACT HIP SYSTEM WITH U-CAP
- K043140 — EXPRESS AND OASIS CHEST DRAIN
- K033260 — AEQUOS
- K042322 — STERICHEK BLOOD LEAK REAGENT STRIPS
- K042452 — RIVA SILVER
- K042723 — TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
- K042946 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
- K042970 — COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
- K043108 — LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
- K043193 — BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
- K030052 — OSTIM
- K040865 — AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
- K042252 — NEXFLEX TOTAL HIP SYSTEM
- K042675 — FLEXI-STAT SP02 EAR SENSOR
- K042817 — MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
- K042929 — ESTENIA C&B
- K043186 — H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
- K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
- K041834 — ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM
- K042148 — HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
- K042284 — UNIMIDE
- K042406 — OLYMPUS LACTATE, OSR6193
- K042427 — GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
- K042548 — CERASYS - ZR
- K042840 — SHIMADZU COLLIMATOR R-20J
- K042856 — CONTOUR FOREHEAD/BROWLIFT THREAD
- K042858 — 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
- K042860 — CORRECT DENTAL IMPRESSION MATERIAL
- K042862 — BD ONECATH
- K042920 — HOVEROUND SE-3 POWERCHAIR
- K042967 — A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
- K043023 — PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
- K043069 — HOVEROUND E100 POWER CHAIR
- K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- K041693 — WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
- K042409 — MODULAR ARTHRODESIS NAIL
- K042576 — COATEST SP FVIII
- K042932 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML
- K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
- K043027 — MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
- K033732 — MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
- K040888 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
- K041047 — ULTRADENT CARBON MASK - UPI #342
- K041063 — SMARTWAVE MS 2000
- K041913 — POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
- K041957 — EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
- K042282 — UNISILK
- K042283 — UNIPRO
- K042286 — UNIESTER C
- K042333 — CONTROL PLASMA N, PROC CONTROL PLASMA
- K042395 — OUTPATIENT III MINOR SURGERY LIGHT
- K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
- K042519 — GAMMA-B 1,25-DIHYDROXY VITAMIN D
- K042547 — DRAGON HEART PISTON SYRINGE
- K042777 — HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
- K042823 — COSMEDENT PIT & FISSURE SEALANT
- K042828 — OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
- K043000 — MODIFICATION TO D-TRONPLUS
- K043001 — MX POLYAXIAL PEDICLE SCREW
- K043019 — VASCULAR SOLUTIONS SCLERO-KIT
- K043115 — LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
- K040744 — ATRILAZE SOFT TISSUE ABLATION SYSTEM
- K040985 — PUMP CONNECTIVITY INTERFACE
- K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL
- K041432 — ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
- K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
- K041708 — ENPATH SAFETY INTRODUCER
- K042382 — DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
- K042520 — VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
- K042744 — OPTIV ANTAGE DH POWER INJECTION SYSTEM
- K042950 — VAG O SPECULUM, MODELS VS1, VM1, VL1
- K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
- K030275 — MB SYSTEM, BIOENERGY LIGHT THERAPY
- K042890 — TRIAGE D-DIMER TEST, MODEL 98100
- K042919 — FIBROTEK FIB
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