FDA 510(k) clearances — page 454

176,542 clearances on record, most recent first.

Clearances — page 454

45,301–45,400 of 176,542

K120135 — 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0Tomtec Imaging Systems GmbH·Product code LLZ·2012-04-13
K120161 — ALPHAPOINT IMAGING SOFTWARERadlogics, Inc.·Product code LLZ·2012-04-13
K120292 — CAPLOX II PEDICLE SCREW SYSTEMCaptiva Spine, Inc.·Product code MNI·2012-04-13
K120300 — CT-GUIDE NEEDLE GUIDANCE SYSTEMActiviews, Ltd.·Product code JAK·2012-04-13
K120315 — SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSIONSiemens Medical Solutions USA, Inc.·Product code LLZ·2012-04-13
K120331 — SYNGO CT DYNAMIC ANGIOSiemens AG Medical Solutions·Product code JAK·2012-04-13
K120703 — ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEMZonare Medical Systems, Inc.·Product code IYN·2012-04-13
K120794 — ASCEND SHOULDER SYSTEMTornier, Inc.·Product code KWS·2012-04-13
K120805 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATUREAngioslide, Ltd.·Product code LIT·2012-04-13
K120972 — FLEXITOUCH SYSTEMTactile Systems Technology, Inc.·Product code JOW·2012-04-13
K110333 — NATURALASE CO2 LASER SYSTEMFocus Medical, LLC·Product code ONG·2012-04-12
K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLC·Product code BZT·2012-04-12
K111547 — BILI-THERAPY PAD TYPEAtom Medical Corporation·Product code LBI·2012-04-12
K112215 — HEMCON HEMOSTATIC GELHemcon Medical Technologies Europe, Ltd.·Product code QSY·2012-04-12
K112398 — TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORTGalt Medical·Product code DYB·2012-04-12
K113186 — STERILE INSULIN PEN NEEDLEShina Corp.·Product code FMI·2012-04-12
K113583 — CURAD ANTIBACTERIAL BANDAGEMedline Industries, Inc.·Product code FRO·2012-04-12
K113768 — U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code LFR·2012-04-12
K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTEParkell, Inc.·Product code MVL·2012-04-12
K120209 — PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLEAmerican I.V. Products, Inc.·Product code MRZ·2012-04-12
K103227 — ORATECT ORAL FLUID DRUG SCREEN DEVICESBranan Medical Corporation·Product code DIO·2012-04-11
K112073 — INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...Rx Devices, LLC·Product code FPA·2012-04-11
K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEMAscension Orthopedic·Product code KWS·2012-04-11
K113533 — NEURO CHECK DEVICE WITH IO-FLEX WIREBaxano, Inc.·Product code HAE·2012-04-11
K113847 — BORRELIA BURGDORFERI IGG BLOT TESTGold Standard Diagnostics·Product code LSR·2012-04-11
K120252 — RAUMEDIC-ICP-TEMP-MONITORING-SYSTEMRaumedic AG·Product code GWM·2012-04-11
K120264 — KONAN SPECULAR MICROSCOPE XIVKonan Medical, Inc.·Product code NQE·2012-04-11
K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCHCalibra Medical, Inc.·Product code OPP·2012-04-10
K112110 — STERILE LUBRICATING JELLYJianerkang Medical Dressing Company·Product code KMJ·2012-04-10
K112989 — AQUILION CXLToshiba America Medical Systems, In.C·Product code JAK·2012-04-10
K113466 — AQUILION ONEToshiba Medical Systems Coporation, Japan·Product code JAK·2012-04-10
K113548 — PEDCATCurvebeam, LLC·Product code JAK·2012-04-10
K113608 — DEFLEXNuxen S.R.L.·Product code EBI·2012-04-10
K120157 — MINI MAXLOCK EXTREME PLATING SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2012-04-10
K120390 — SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SETSolana Surgical, LLC·Product code HWC·2012-04-10
K120774 — ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LTWelch Allyn, Inc.·Product code DSI·2012-04-10
K112149 — WEIGHT AND BODY FAT SCALE SHINE BS0105Shine Overseas Marketing Limited·Product code MNW·2012-04-09
K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension Orthopedic·Product code KXE·2012-04-09
K112653 — ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMSACON Laboratories, Inc.·Product code JJX·2012-04-09
K120349 — SONIXGPS VASCULAR ACCESS NEEDLE KITUltrasonix Medical Corpation·Product code DRE·2012-04-09
K120368 — CAPSTONE CONTROL SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2012-04-09
K120473 — PIXEL APPGauss Surgical, Inc.,·Product code LWH·2012-04-09
K120477 — AEROSYNC FOR AERODR SYSTEMKonica Minolta Medical & Graphic, Inc.·Product code MQB·2012-04-09
K111997 — IMAGE1 GI CCU MODEL 22203020-114KARL STORZ Endoscopy-America, Inc.·Product code FET·2012-04-06
K112505 — ETHEREARegulatory Insight, Inc.·Product code GEX·2012-04-06
K112899 — ARTHREX BIO-SUTUREArthrex, Inc.·Product code GAT·2012-04-06
K113170 — CERVICAL PLATEEisertech, LLC·Product code KWQ·2012-04-06
K113463 — POWER WHEELCHAIRSuzhou KD Medical Appliance Co., Ltd.·Product code ITI·2012-04-06
K120095 — SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HANDDepuy Mitek, A Johnson & Johnson Company·Product code GEI·2012-04-06
K120187 — MULTI-MODALITY IMAGE FUSIONIgt, LLC Dba Eigen·Product code LLZ·2012-04-06
K120279 — NANOFUSE DBMNanotherapeutics·Product code MQV·2012-04-06
K120361 — SYNAPSE 3D BASE TOOLSFujifilm Medical Systems U.S.A, Inc.·Product code LLZ·2012-04-06
K120387 — RAYSTATIONRaysearch Laboratories AB·Product code MUJ·2012-04-06
K120388 — INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEMHologic, Inc.·Product code OXO·2012-04-06
K120448 — MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROLApex BioTechnology Corp.·Product code CGA·2012-04-06
K120613 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·Product code OXO·2012-04-06
K120709 — THE DOME GX4MP COLOR NONITORNds Surgical Imaging·Product code LLZ·2012-04-06
K120710 — AQUILION PRIMEToshibamedical Systems Corporation·Product code JAK·2012-04-06
K120721 — EOSEos Imaging·Product code MQB·2012-04-06
K110481 — TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASEAsi Medical, Inc.·Product code EIA·2012-04-05
K111453 — STEAM DOT BLU PROCESS INDICATORPropper Mfg. Co., Inc.·Product code JOJ·2012-04-05
K112470 — 2GC HIP/KNEE MODULAR SPACERMandell Horwitz Consultants, LLC·Product code KWL·2012-04-05
K113502 — ADVANTAGE LASER SYSTEMLutronic Corporation·Product code GEX·2012-04-05
K113554 — CMI IMPLANT IS SYSTEMNeobiotech Co., Ltd.·Product code DZE·2012-04-05
K113626 — INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRSorin Group Italia S.R.L.·Product code DTZ·2012-04-05
K113640 — STELLAR 150Resmed Germany, Inc.·Product code MNT·2012-04-05
K113674 — SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANTHandpiece Headquarters, Inc. - Hpr, Inc.·Product code EFB·2012-04-05
K113677 — GRINDCARE MEASUREMedotech A/S·Product code KZM·2012-04-05
K120003 — NUCALPulpdent Corporation·Product code EJK·2012-04-05
K120570 — CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEMChoicespine, LP·Product code MQP·2012-04-05
K120697 — EAGLE EYE PLATINUM ST CATHETERVolcano Corporation·Product code OBJ·2012-04-05
K120828 — BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESColoplast A/S·Product code FRO·2012-04-05
K111274 — JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038Jetprep, Ltd.·Product code OCX·2012-04-04
K111480 — MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CMTechnology Delivery Systems, Inc.·Product code FGB·2012-04-04
K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTFocus Diagnostics, Inc.·Product code OMN·2012-04-04
K120656 — EVEREST SPINAL SYSTEMK2m, Inc.·Product code MNI·2012-04-04
K120667 — VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOTSmith & Nephew, Inc.·Product code HRS·2012-04-04
K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETERCovidien·Product code MPB·2012-04-04
K120686 — ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEMCodman & Shurtleff, Inc.·Product code HCG·2012-04-04
K111636 — REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAMGunnell, Inc.·Product code IOR·2012-04-03
K113115 — EPICARE YAGLight Age, Inc.·Product code GEX·2012-04-03
K113144 — PAGEWRITER TC 20, 30, 50, 70Philips Medical Systems·Product code DPS·2012-04-03
K113361 — SECURIS SPINAL FIXATIONCumtom Spine·Product code NKB·2012-04-03
K113371 — STAPHYLOCOCCUS QUICKFISH BCAdvandx, Inc.·Product code NXX·2012-04-03
K113759 — AVAIRA (ENFILCON A) CONTACT LENSCooperVision, Inc.·Product code LPL·2012-04-03
K120065 — PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIESPlaxtron Industrial (M) Sdn. Bhd.·Product code JCX·2012-04-03
K120069 — MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.·Product code DTL·2012-04-03
K120204 — REPROCESSED FEMORAL COMPRESSION DEVICESterilmed, Inc.·Product code NMF·2012-04-03
K120238 — RTVUE XR OCTOptovue, Inc.·Product code HLI·2012-04-03
K120670 — HAMILTON-T1Hamilton Medical AG·Product code CBK·2012-04-03
K120694 — ENCORE 26 ADVANTAGE KITBoston Scientific Corp·Product code MAV·2012-04-03
K111695 — HYBRID GRAFTCook Biotech, Inc.·Product code FTL·2012-04-02
K112247 — A BAER WITH ABAER I/O FUNCTIONNatus Medical Incorporated·Product code EWO·2012-04-02
K112426 — XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBESXian Friendship Medical Electronics Co., Ltd.·Product code ETN·2012-04-02
K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )Small Bone Innovations, Inc.·Product code HSB·2012-04-02
K113829 — ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEMaterialise NV·Product code JWH·2012-04-02
K120190 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLORRich Mountain Medical Products, Inc.·Product code LYZ·2012-04-02
K120330 — PENUMBRA COIL SYSTEM/PENUMBRA COIL 400Penumbra, Inc.·Product code HCG·2012-04-02
K120433 — CLEAR + BRILLIANT LASER SYSTEMSolta Medical, Inc.·Product code ONG·2012-04-02
K120696 — TIGER SPINE SYSTEMCorelink, LLC·Product code MNI·2012-04-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.