FDA 510(k) clearances — page 492

176,542 clearances on record, most recent first.

Clearances — page 492

49,101–49,200 of 176,542

K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEMSynthes (Usa)·Product code HRS·2011-01-21
K103529 — LIAISON XL ANALYZER MODEL 10050DiaSorin, Inc.·Product code LOL·2011-01-21
K103580 — GRANDIO SO FLOWVoco GmbH·Product code EBF·2011-01-21
K103746 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)Biosense Webster, Inc.·Product code DQK·2011-01-21
K103755 — TAPERLOC COMPLETE, SIZE 5 AND 6Biomet Manufacturing Corp·Product code KWA·2011-01-21
K110131 — LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE3M Espe Dental Products·Product code EBF·2011-01-21
K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900Gaymar Industries, Inc.·Product code DWJ·2011-01-20
K100610 — LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSLutronic Corporation·Product code ONG·2011-01-20
K101446 — EMERALD SPINAL SYSTEMMazor Surgical Technologies , Ltd.·Product code MNH·2011-01-20
K102153 — MOBIUS ULTRASOUND IMAGING SYSTEMMobisante, Inc.·Product code IYO·2011-01-20
K102203 — CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTSChemtron Biotech, Inc.·Product code DKZ·2011-01-20
K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions Limited·Product code HWE·2011-01-20
K102814 — ELECYSYS SHBGRoche Diagnostics·Product code CDZ·2011-01-20
K102893 — PCP/PC STETHOSCOPERnk Products, Inc.·Product code DQD·2011-01-20
K102914 — TQ HBA1C GEN3Roche·Product code LCP·2011-01-20
K102940 — VASCOPRESS SEQUENTIAL DVT PUMPCompression Therapy Concepts·Product code JOW·2011-01-20
K103017 — MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULEMederi Therapeutics, Inc.·Product code GEI·2011-01-20
K103351 — DMC COMPOSITE 2Kerr Corporation·Product code EBF·2011-01-20
K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)Sorin Group Deutschland GmbH·Product code DWA·2011-01-20
K103539 — QUANTA SYSTEM DUOLITEQuanta System Spa·Product code GEX·2011-01-20
K103715 — COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSUREMirador Biomedical, Inc.·Product code DRS·2011-01-20
K103762 — SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLESorin Group Deutschland GmbH·Product code DTQ·2011-01-20
K110020 — TERASON T3200 ULTRASOUND SYSTEMTeratech Corp.·Product code ITX·2011-01-20
K102165 — STERILE SALINE SOLUTIONCachet Pharmaceuticals Pvt. , Ltd.·Product code LPN·2011-01-19
K102195 — SP-FIX SPINOUS PROCESS FIXATION PLATEGlobus Medical, Inc.·Product code KWP·2011-01-19
K102370 — R3 XLPE ANTEVERTED LINERSSmith & Nephew, Inc.·Product code MBL·2011-01-19
K102594 — IO-FLEX CATHETERBaxano, Inc.·Product code BSO·2011-01-19
K103080 — ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.·Product code MAL·2011-01-19
K103250 — CPS DIRECT SL II SLITTABLE OUTER CATHETERSt. Jude Medical, Cardiac Rhythm Management Divisi·Product code DQY·2011-01-19
K103533 — ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MMAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2011-01-19
K103710 — WBR XPRESS PETUltraspect , Ltd.·Product code KPS·2011-01-19
K083894 — ALIF SPINAL TRUSS INTERBODY FUSION DEVICE4-Web Spine, LLC·Product code MAX·2011-01-18
K093627 — IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650Shanghai Apolo Medical Technologies Co., Ltd.·Product code ONF·2011-01-18
K101599 — RVT CTO DEVICERevascular Therapeutics, Inc.·Product code PDU·2011-01-18
K102979 — NEXGEN PERIPHERAL GUIDE CATHETERNexgen Medical Systems, Inc.·Product code DQY·2011-01-18
K103133 — VEPER SYSTEM, EXPEDIUM SYSTEMDepuy Spine, Inc.·Product code NKB·2011-01-18
K103334 — CARDIO MEDCardio Medical Products, Inc.·Product code LDD·2011-01-18
K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbH·Product code KRL·2011-01-18
K092963 — GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3Genx Intl., Inc.·Product code MQL·2011-01-14
K100649 — SOUNDBITE HEARING SYSTEM BY SONITUSSonitus Medical, Inc.·Product code LXB·2011-01-14
K100829 — EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520Medica Corp.·Product code JGS·2011-01-14
K101216 — AUDIT MICROCV PROTEIN LINEARITY SETAalto Scientific, Ltd.·Product code JJY·2011-01-14
K101336 — E1 AVANTAGE HEADBiomet Manufacturing Corp·Product code LPH·2011-01-14
K102077 — MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEMCma Microdialysis AB·Product code GWM·2011-01-14
K102385 — NORFOLK MEDICAL NORPORT FAMILY OF PORTSNorfolk Medical Products, Inc.·Product code LJT·2011-01-14
K102432 — DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,Diazyme Laboratories·Product code MRG·2011-01-14
K102584 — IMC HYPODERMIC NEEDLEInternational Medsurg Connection·Product code FMI·2011-01-14
K102589 — CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETERCodman & Shurtleff, Inc.·Product code JXG·2011-01-14
K102601 — ORTHOFLEX RODOrtho-Pro, LLC·Product code KWH·2011-01-14
K102857 — AHWON'S IPL SYSTEMAhwon Medi Instrument Co., Ltd.·Product code ONF·2011-01-14
K102864 — 84E SERIES SINGLE PLY WRAPPERLac Mac, Ltd.·Product code FRG·2011-01-14
K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EXStryker Corp.·Product code JEC·2011-01-14
K102934 — INFRARED EAR THERMOMETER, MODEL IR-04MTVega Technologies, Inc.·Product code FLL·2011-01-14
K102959 — PROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.·Product code JGS·2011-01-14
K103032 — ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJOlympus Winter & Ibe GmbH·Product code GEI·2011-01-14
K103068 — KING COBRA ANTERIOR CERVICAL PLATEEminent Spine·Product code KWQ·2011-01-14
K103088 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELTGiven Imaging , Ltd.·Product code NEZ·2011-01-14
K103182 — TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMGenoray Co., Ltd.·Product code LLZ·2011-01-14
K103353 — MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETERNavilyst Medical, Inc.·Product code FGE·2011-01-14
K103501 — ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIESAlma Lasers, Inc.·Product code GEX·2011-01-14
K103688 — G-PROX EZ ENDOSCOPIC GRASPERUsgi Medical·Product code OCZ·2011-01-14
DEN090011 — HEM-AVERT PERIANAL STABILIZERPlexus Biomedical, Inc.·Product code OOA·2011-01-13
K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793Bio-Rad·Product code NOM·2011-01-13
K100891 — DANA EMULATING INDICATORDana Products, Inc.·Product code JOJ·2011-01-13
K101614 — HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809Dm Systems, Incorporated·Product code DWL·2011-01-13
K102140 — FETAL MONITORS, MODELS F2 AND F3Edan Instruments, Inc.·Product code HGM·2011-01-13
K102460 — AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATHSummit Medical Products, Inc.·Product code BSO·2011-01-13
K102590 — FLEBOSET DOUBLELaboratorios Grifols, S.A.·Product code LHI·2011-01-13
K102613 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESHebei Favor Plastic Co., Ltd.·Product code LYZ·2011-01-13
K102836 — BONASIL A+ IMPRESSION MATERIALSDmp, Ltd.·Product code ELW·2011-01-13
K102861 — SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)A Plus International, Inc.·Product code KKX·2011-01-13
K102996 — MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSORMedivators Reprocessing Systems·Product code FEB·2011-01-13
K103232 — CASPIAN SPINAL SYSTEMK2m, Inc.·Product code KWP·2011-01-13
K103652 — SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8Philips Medical Systesms·Product code MHX·2011-01-13
K101904 — SMARTXIDE 50 HS/MSEl.En Electronic Engineering Spa·Product code GEX·2011-01-12
K102121 — ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBARApollo Spine, Inc.·Product code OVD·2011-01-12
K102338 — BREATHSCN PROAkers Biosciences, Inc.·Product code DJZ·2011-01-12
K102506 — MIXED MEDIA MARKERCortex Manufacturing, Inc.·Product code NEU·2011-01-12
K102651 — ISCREEN VISION SCREENERIscreen Vision, Inc.·Product code HKI·2011-01-12
K102834 — ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)Kinamed, Incorporated·Product code JDQ·2011-01-12
K102872 — OSBONE DENTALCurasan AG·Product code LYC·2011-01-12
K102915 — VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEMViewray, Incorporated·Product code MUJ·2011-01-12
K103070 — GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +G Surgical Co., Ltd.·Product code KWQ·2011-01-12
K103144 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCERShantou Institute of Ultrasonic Instruments (Siui·Product code IYN·2011-01-12
K103365 — DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY AGe Healthcare Coils (Usa Instruments, Inc.)·Product code MOS·2011-01-12
K103394 — BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)Varian Medical Systems, Oncology Systems·Product code IYE·2011-01-12
K103645 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEMToshiba Medical Systems Corporation, Japan·Product code ITX·2011-01-12
K110030 — EXPECT ENDOSCOPIC ASPIRATION NEEDLEBoston Scientific Corp·Product code ODG·2011-01-12
K092183 — EMBRYOSCOPE AND EMBRYOSLIDEUnisense Fertilitech A/S·Product code MQG·2011-01-11
K101535 — BT-CATHUtah Medical Products, Inc.·Product code OQY·2011-01-11
K101716 — HVR PAIN RELIEF DEVICEH.V.R., Inc.·Product code ILY·2011-01-11
K101995 — CAPNOSTREAM 20P WITH MASIMO SPO2 BOARDOridion Capnography, Inc.·Product code DQA·2011-01-11
K102781 — RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDSOlympus Winter & Ibe GmbH·Product code FAS·2011-01-11
K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100Cardio Medical Products, Inc.·Product code LDD·2011-01-11
K103275 — SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMSSiemens Medical Solutions USA, Inc.·Product code MOS·2011-01-11
K103470 — PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAPB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.·Product code GDW·2011-01-11
K102508 — YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02Yu Long Sheng Technology Co., Ltd.·Product code FLL·2011-01-10
K102617 — AUDIT MICROCV CARDIAC MARKERS LINEARITY SETAalto Scientific, Ltd.·Product code JJY·2011-01-10
K102822 — IMPLANT-ONE SYSTEMCustom Dental Implants, Inc.·Product code DZE·2011-01-10
K103033 — TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXXZimmer Trabecular Metal Technology·Product code ODP·2011-01-10

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