FDA 510(k) clearances — page 460

176,542 clearances on record, most recent first.

Clearances — page 460

45,901–46,000 of 176,542

K103295 — QUICKSCREEN COCAINE 150 SCREENING TESTPhamatech, Inc.·Product code DIO·2012-02-01
K110691 — ONE PERSONAL LUBRICANT (WATER BASED)One·Product code NUC·2012-02-01
K110899 — GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITGold Standard Diagnostics·Product code LYR·2012-02-01
K111364 — HAPTITE COATING IMPLANT SYSTEMDentis Co., Ltd.·Product code DZE·2012-02-01
K111411 — FREEMIE (R)Dao Health·Product code HGX·2012-02-01
K111515 — SPSMEDICAL SPORVIEW STEAM BISpsmedical Supply Corp.·Product code FRC·2012-02-01
K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,Ltd·Product code ITH·2012-02-01
K112650 — CONNEXALL SUITE OF SOFTWARE PRODUCTSConnexall USA, Inc.·Product code MSX·2012-02-01
K112736 — PASS LP SPINALMedicrea International·Product code JDQ·2012-02-01
K112906 — KLASSIC KNEE SYSTEMTotal Joint Orthopedics, Inc.·Product code JWH·2012-02-01
K113053 — BIPAP A 30 VENTILATORY SUPPORT SYSTEMRespironics, Inc.·Product code MNS·2012-02-01
K113149 — SYNTHES USS CONNECTORSSynthes Spine·Product code MNI·2012-02-01
K113308 — BRUNO ELAN STAIRWAY ELEVATORBruno Independent Living Aids, Inc.·Product code ILK·2012-02-01
K113623 — PATIENT MONITOREdan Instruments, Inc.·Product code MHX·2012-02-01
K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)Angiotech·Product code NEW·2012-02-01
K113755 — SAVANNAH TECHNOLOGIES SPINAL SYSTEMSavannah Technologies, LLC·Product code MNI·2012-02-01
K111305 — UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417WMeridian Medical Systems, LLC·Product code MQB·2012-01-31
K112143 — AUDIT MICROCV T-UPTAKE LINEARITYAalto Scientific, Ltd.·Product code JJX·2012-01-31
K112526 — TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORSSmith & Nephew, Inc.·Product code MBI·2012-01-31
K113014 — CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWSWrightmedicaltechnologyinc·Product code HRS·2012-01-31
K113525 — ACTIVECARE DVT ACTIVECARE+SFTMedical Compression Systems (Dbn) , Ltd.·Product code JOW·2012-01-31
K120058 — TRANSTEK BLOOD PRESSURE MONITORZhongshan Transtek Electronics Co., Ltd.·Product code DXN·2012-01-31
K111332 — CLARITY OBP SYSTEMElekta , Ltd.·Product code IYE·2012-01-30
K111385 — DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLEQubyx Limited·Product code LLZ·2012-01-30
K111413 — BIOGEL (R) INDICATOR (R) UNDERGLOVEMolnlycke Health Care Us, LLC·Product code KGO·2012-01-30
K112018 — SMART READ EZTEST STEAMMesa Laboratories, Inc.·Product code FRC·2012-01-30
K112333 — LRT ATTACHMENTBcf Certification, Inc.·Product code NHA·2012-01-30
K112539 — CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBELeiker Regulatory & Quality Consulting·Product code IYO·2012-01-30
K112600 — ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KITAngioDynamics, Inc.·Product code GEX·2012-01-30
K112720 — MCKESSON HORIZON CARDIOLOGYMckesson Israel , Ltd.·Product code LLZ·2012-01-30
K113015 — ALDAHOL V HIGH LEVEL DISINFECTANTMicrochem Laboratories, Inc.·Product code MED·2012-01-30
K113048 — MAXLOCK EXTREME SYSTEMOrthohelix Surgical Designs, Inc.·Product code HRS·2012-01-30
K113076 — CAAS A-VALVEPie Medical Imaging BV·Product code LLZ·2012-01-30
K113555 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGEAm USA·Product code NGT·2012-01-30
K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIABionostics, Inc.·Product code JJX·2012-01-30
K102383 — MICRODOT & MICRODOT XTRACambridge Sensors Limited·Product code NBW·2012-01-27
K111294 — SANTORINI SPINAL SYSTEMK2m, Inc.·Product code MQP·2012-01-27
K111595 — NEUMOVENT GRAPHNETTecme S.A.·Product code CBK·2012-01-27
K112233 — BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADEBovie Medical Corporation·Product code GEI·2012-01-27
K112319 — ELECTRO-CAP SYSTEMElectro-Cap Intl., Inc.·Product code GXY·2012-01-27
K112804 — FINGERTIP PULSE OXIMETERGuangdong Biolight Meditech Co., Ltd.·Product code DQA·2012-01-27
K112875 — BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMSBlue Sky Bio, LLC·Product code DZE·2012-01-27
K112879 — REST ASSURED READY TO WEAR NITE PROTECTORRanir, LLC·Product code OBR·2012-01-27
K113049 — SOCKET GRAFTSteiner Laboratories·Product code LYC·2012-01-27
K113141 — MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1Microlife Intellectual Property GmbH·Product code FLL·2012-01-27
K113185 — MODEL HBP-1300Omron Healthcare, Inc.·Product code DXN·2012-01-27
K113273 — SPOTLIGHT ACCESS SYSTEMJohnson & Johnson·Product code GZT·2012-01-27
K113486 — VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEMVolcano Corporation·Product code IYO·2012-01-27
K113522 — PATHASSIST LIGHT SEEKEREntellus Medical, Inc.·Product code LRC·2012-01-27
K113524 — VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KITMaine Standards Co.·Product code JJX·2012-01-27
K113571 — GMK RESUFACING PATELLA SIZE 4Medacta International·Product code JWH·2012-01-27
K113606 — NNC GOLD ABUTMENT FOR BRIDGESStraumann USA·Product code NHA·2012-01-27
K113718 — NCB STRAIGHT NARROW SHAFT PLATESZimmer GmbH·Product code HRS·2012-01-27
K113842 — CATHETER CONNECTIONS' DUALCAP SOLOCatheter Connections, Inc.·Product code QBP·2012-01-27
K102541 — CYNOSURE CELLULAZE LASERCynosure, Inc.·Product code OYW·2012-01-26
K110066 — AQUILION PRIMEToshiba America Medical Systems, In.C·Product code JAK·2012-01-26
K110312 — CLICKFINE AUTOPROTECT PEN NEEDLEYpsomed AG·Product code FMI·2012-01-26
K111134 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGSSiem Aempemed Corp., Ltd.·Product code LZA·2012-01-26
K111232 — GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc.·Product code HSB·2012-01-26
K111786 — HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEMStryker Corp.·Product code KTT·2012-01-26
K111986 — LOGIC LAPAROSCOPIC INSTRUMENT SYSTEMSurgical Innovations Plc·Product code GEI·2012-01-26
K112044 — ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24AAnaxdent GmbH·Product code EBF·2012-01-26
K112045 — SIMPLELINE II ABUTMENT SYSTEMDentium Co., Ltd.·Product code NHA·2012-01-26
K112427 — BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.·Product code FIN·2012-01-26
K112429 — GIZA(R) VERTEBRAL BODY REPLACEMENTEden Spine, LLC·Product code MQP·2012-01-26
K112820 — FORE-SIGHT ABSOLUTE TISSUE OXIMETERCas Medical Systems, Inc.·Product code MUD·2012-01-26
K112959 — CALG-STR EXERCISE ECG ANALYSIS ALGORITHMPhilips Health Care·Product code DPS·2012-01-26
K113030 — SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICESpineology, Inc.·Product code MAX·2012-01-26
K113184 — LOGICSCAN 64 LOGICSCAN 128Telemed·Product code IYN·2012-01-26
K113208 — GAL-1A BLOOD GLUCOSE MONITORING SYSTEMApex BioTechnology Corp.·Product code CGA·2012-01-26
K113218 — PIONEER RELEASE LAMINOPLASTY PLATING SYSTEMPioneer Surgical Technology, Inc.·Product code NQW·2012-01-26
K113447 — RISE SPACERGlobus Medical, Inc.·Product code MAX·2012-01-26
K113644 — PILOT TUBE REPAIR KITInstrumentation Industries, Inc.·Product code BSK·2012-01-26
K120073 — INFX-8000V WITHToshibamedical Systems Corporation·Product code OWB·2012-01-26
K120075 — AM-6000 ANESTHESIA MACHINEAdvanced Instrumentations, Inc.·Product code BSZ·2012-01-26
K111337 — TORNIER COLLAGEN COATED BIOFIBER SCAFFOLDTornier, Inc.·Product code FTL·2012-01-25
K111634 — XENON(TM) PEDICLE SCREW SYSTEMAlphatec Spine, Inc.·Product code NKB·2012-01-25
K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEMSeaspine, Inc.·Product code KWQ·2012-01-25
K112251 — SWISSMEDA DENTAL PLANNING SYSTEMSwissmeda AG·Product code LLZ·2012-01-25
K112312 — THERATRODEPhoenix Medical Devices, Llp·Product code GXY·2012-01-25
K112576 — ENDOCHOICE WATER BOTTLE CAP SYSTEMEndochoice, Inc.·Product code FEQ·2012-01-25
K112981 — SUN 125C IONIZATION CHAMBERSun Nuclear Corp.·Product code LHN·2012-01-25
K113632 — DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.·Product code IYO·2012-01-25
K113663 — SONIXTABLET ULTRASOUND SCANNERUltrasonix Medical Corporation·Product code IYN·2012-01-25
K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACEMedtronic, Inc.·Product code DTL·2012-01-25
K113855 — PANORAD, PANORAD SLImix Adr Finland OY·Product code KPR·2012-01-25
K110923 — COBAS 4800 CT / NG TESTRoche Molecular Systems, Inc.·Product code MKZ·2012-01-24
K111877 — EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTIONBausch & Lomb, Inc.·Product code LPN·2012-01-24
K112705 — AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROLAalto Scientific, Ltd.·Product code JJY·2012-01-24
K112858 — GENESIS TOUCH SYSTEMHoneywell Hommed, LLC·Product code DRG·2012-01-24
K112904 — STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTSCase Medical, Inc.·Product code FRG·2012-01-24
K113059 — CONTIPLEX FXB.Braun Medical, Inc.·Product code CAZ·2012-01-24
K113154 — IVAS BALLOON CATHETERStryker Corporation·Product code NDN·2012-01-24
K113167 — MTF NEW BONE VOILD FILLERMusculoskeletal Transplant Foundation·Product code MQV·2012-01-24
K113858 — MEGABEAM ENDO-ENT PROBEBiolitec Medical Devices, Inc.·Product code GEX·2012-01-24
K110534 — RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3Randox Laboratories Limited·Product code JJY·2012-01-23
K111971 — SYNDE-LOCK SYNDESMOSIS REPAIR KITTarsus Medical, Inc.·Product code HWC·2012-01-23
K112574 — PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENTPrime Dental Manufacturing, Inc.·Product code EMA·2012-01-23
K112808 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESOmega Laboratories, Inc.·Product code DIO·2012-01-23
K113092 — ZIMMER CONTOUR PROVISIONAL COPINGZimmer Dental, Inc.·Product code NHA·2012-01-23

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