FDA 510(k) clearances — page 502
clearances on record, most recent first.
Clearances — page 502
50,101–50,200 of 176,542- K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
- K100578 — ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
- K100793 — UROSTATION 3D PROSTATE SUITE
- K101097 — CALGAESEAL MODEL: CAS
- K101697 — ENSITE VERISMO SEGMENTATION TOOL V.2.0
- K100479 — PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
- K100845 — PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
- K101761 — EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13
- K101983 — CRITICAL CARE ASSESSMENT
- K102462 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K092734 — E-LIGHT LINE
- K093694 — GERATHERM UNIQUERESC
- K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
- K100969 — WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N
- K101039 — SHIMADZU COLLIMATOR R-300
- K101568 — MODEL SB100II FINGER PULSE OXIMETER
- K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
- K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
- K101689 — EMM EQUIPMENT COVER-POLYTHYLENE
- K101740 — ALBOSURE POLYESTER VASCULAR PATCH
- K101771 — RELINE-IT MODEL RELINE-IT
- K102017 — SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K102356 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
- K091467 — BABY QUASAR
- K094003 — REVIVATOR
- K100657 — V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U
- K100787 — RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
- K101157 — E-BASIC SINGLE BREAST PUMP
- K101170 — ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
- K101245 — ULTRASEAL ID
- K101366 — I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
- K101420 — GC FUJI TEMP
- K101555 — CO2 LASER SYSTEM
- K101906 — SHAPE TO FIT COMPRESSION WEAR
- K102021 — CRYO-TOUCH II
- K102353 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
- K094050 — ITOTAL CR KNEE REPLACEMENT SYSTEM
- K101129 — ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
- K101587 — PROPATCH SOFT TISSUE REPAIR MATRIX
- K101661 — MYRAY HYPERION
- K093254 — AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
- K100029 — MEPILEX BORDER AG DRESSING
- K100726 — CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
- K101373 — EMBRACE
- K101375 — TRIMED X-FIX
- K101426 — CEROS TCP GRANULES
- K101429 — ECO SUPERGEL
- K101435 — IMIX PANORAD AND SOMARAD
- K101505 — RTVUE MODEL RTVUE 100
- K101536 — 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
- K101968 — SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
- K102174 — ZOLL PROPAQ M
- K102291 — COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
- K092551 — SMITH & NEPHEW INSTRUMENT TRAYS
- K093960 — ST AIA-PACK CYSTATIN C, MODEL 025217
- K100221 — INTELLIWAVE3
- K100727 — LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
- K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
- K101496 — CABLECAP MODEL: WLF, STZ, ACM
- K101976 — INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
- K101977 — TAPERED SCREW-VENT T IMPLANT
- K092794 — TRANSCORP ACIF SYSTEM
- K100017 — EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
- K100899 — OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
- K101380 — RXPEAKFLOW
- K101676 — CLEARARCH
- K101783 — COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
- K101824 — AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
- K102173 — MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
- K091952 — ACTA VESSEL OCCLUSION SYSTEM (VOS)
- K093367 — STERILE SALINE SOLUTION
- K093901 — SURGICAL FACE MASK
- K094049 — STLASE DIODE LASER
- K100736 — KIRSCHNER AND GUIDE WIRES
- K101203 — TINA-QUANT ALBUMIN GEN 2
- K101288 — STAXX XD SYSTEM
- K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
- K101696 — MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
- K102004 — ENDEAVOUR MONITORING SYSTEM
- K102230 — NUGARD NITILE GREY COLOR
- K102267 — ELECSYS FERRITIN CALCHECK 5
- K102303 — BLOOD PRESSURE METER, MODEL CH-658
- K102430 — TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
- K102442 — E.S.O. (ELECTRO SENSOR OXI)
- K100853 — COBAS 8000 MODULAR SERIES ANALYZER
- K100985 — BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
- K101551 — PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
- K101885 — MEDTRONIC C315 DELIVERY CATHETER
- K093723 — EMS MINIMASTER LED
- K101249 — STERIGAGE MODEL 1243RA, 1243RB, 1243RE
- K101456 — ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
- K101490 — FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
- K101646 — NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
- K101694 — HANDHELD PULSE OXIMETER MODEL M800
- K101734 — VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
- K101803 — NEWPORT E360 VENTILATOR
- K102032 — KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
- K102118 — SNORE GUARD ADVANCE
- K100442 — FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
- K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
Data sourced from openFDA. This site is unofficial and independent of the FDA.