FDA 510(k) clearances — page 856
clearances on record, most recent first.
Clearances — page 856
85,501–85,600 of 175,890- K992345 — CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
- K992358 — CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
- K992588 — BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
- K992630 — THERMALIGHT 2000
- K992693 — RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
- K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
- K992721 — COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
- K990335 — PHILIPS EASYVISION WORKSTATION:
- K991020 — <GENX> DOUBLE LUMEN NEEDLE
- K991022 — <GENX> SPERM WASHING MEDIA
- K991262 — <GEN>SINGLE LUMEN NEEDLE
- K991264 — <GENX> SINGLE LUMEN SIDEPORT NEEDLE
- K991266 — <GENX> EMBRYO TRANSFER CATHETER CC GLIDER
- K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
- K991969 — HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)
- K991986 — COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
- K992027 — KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR
- K992038 — POCKETSPACER
- K992073 — AX WORKSTATION
- K992091 — PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
- K992112 — SAMSUNG RAYPAX FILM DIGITIZER
- K992237 — MEDTRONIC GT2 FUSION GUIDE WIRES
- K992802 — TERUMO U-100 INSULIN SYRINGE
- K992864 — RENDER-PLAN 3-D
- K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT
- K991754 — GO GLUCOSE MONITORING SYSTEM
- K991996 — IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
- K992013 — DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER
- K992044 — INFUSION DYNAMICS POWER INFUSER MODEL M100B
- K992090 — MILLENNIUM GOLD
- K992135 — SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
- K992259 — ECHOCARDIOGRAPHY SYSTEM SERIES 95000
- K992305 — MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
- K992379 — RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
- K992472 — SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM
- K992640 — SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS
- K992765 — CYNOSURE DIODERM
- K992893 — DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
- K992895 — IMPREGUM F
- K992897 — IMPREGUM PENTA
- K991901 — BIO-97
- K992170 — N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
- K992225 — QUANTITATIVE FLOW
- K992610 — GENDEX 765DC, MODEL 110-0154
- K992868 — DENTAPURE DP40 CARTRIDGE
- K980024 — SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
- K982926 — FRESENIUS BLOOD VOLUME MONITOR
- K984101 — FLEXIBLADE
- K984391 — THE LIBERATOR
- K990148 — STACKABLE CAGE SYSTEM
- K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM
- K990494 — MODIFICATION OF NOGA
- K990689 — ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
- K990762 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
- K990979 — STECO-TITANMAGNETICS
- K991159 — PRISMATHERM II, ASTOLINE
- K991180 — BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
- K991185 — BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
- K991274 — MUMPS IGG ELISA TEST SYSTEM
- K991910 — LIFEPAK 12 BIPHASIC
- K991915 — MODULAR RADIAL HEAD
- K991946 — ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
- K991966 — THE NOMOS CHANE II
- K991973 — CAPIOX SX10 HARDSHELL RESEVOIR
- K991979 — SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
- K992005 — GILTECH PLUS TRANSPARENT DRESSING
- K992023 — GRAND CERAM
- K992063 — OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
- K992077 — PASCO MIC AND MIC/ID PANELS (OFLOXACIN)
- K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K992108 — PASCO MIC AND MIC/ID PANELS (CEFEPIME)
- K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C
- K992137 — UROLOGICAL CATHETER
- K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K992193 — ENDO-ESOPHAGEAL MR COIL
- K992246 — QCT BONE MINERAL ANALYSIS SOFTWARE
- K992280 — LORAD 1-650 (INTERNATIONAL 650)
- K992297 — PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
- K992400 — BACTALERT FA
- K992401 — BACT/ALERT PF
- K992576 — URINE CHEMISTRY CONTROL, LEVEL 1
- K992578 — URINE CHEMISTRY CONTROL, LEVEL 2
- K992659 — O2N DEMAND-II, VICTOR MODEL OCPR-II
- K992677 — EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K992753 — CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
- K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
- K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
- K991112 — SAGE CONTRAST MANAGEMENT SYSTEM
- K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
- K991761 — MAGNESIUM PRODUCT NO'S, 112-01, 112-02
- K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
- K991923 — SOOTHE-N-SEAL CANKER SORE RELIEF
- K991948 — DR. B'S MOUTHPIECE, MODEL 32129-10002
- K992172 — LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
- K992748 — DRUGCHECK X MULTIDRUG SCREENING DEVICE
- K974387 — PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
- K990338 — NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
- K990412 — CUFF-ABLE PLUS
- K990592 — INTRASTENT II
- K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
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