FDA 510(k) clearances — page 398

176,542 clearances on record, most recent first.

Clearances — page 398

39,701–39,800 of 176,542

K131555 — MEDSOURCE IV SAFETY CATHETERMedsource International, LLC·Product code FOZ·2014-01-31
K131571 — AVD RIGHT RADIAL DRAPEAdvanced Vascular Dynamics·Product code KKX·2014-01-31
K131592 — ENLIGHTN RENAL GUIDE CATHETERSt. Jude Medical, Inc.·Product code DQY·2014-01-31
K131696 — VESALIUSTelea Electronic Engineering Srl·Product code GEI·2014-01-31
K131907 — RAYPEX 6Dentsply International, Inc.·Product code LQY·2014-01-31
K132070 — VITA SUPRINITY(R)Vita Zahnfabrik H.Rauter GmbH & Co.·Product code EIH·2014-01-31
K132135 — LINA GOLD LOOP HCLina Medical Aps·Product code KNF·2014-01-31
K132221 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShandong Haoyu Medical Products Co., Ltd.·Product code LYZ·2014-01-31
K132356 — SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40STScican GmbH·Product code EGS·2014-01-31
K132792 — ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINERDaniels Sharpsmart, Inc.·Product code MMK·2014-01-31
K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)Welch Allyn, Inc.·Product code MWI·2014-01-31
K133034 — LOGIQ F SERIESGE Healthcare·Product code IYN·2014-01-31
K133038 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTrek Diagnostic Systems·Product code NGZ·2014-01-31
K133240 — VARIAN MULTILEAF COLLIMATORVarian Medical Systems, Inc.·Product code IYE·2014-01-31
K133343 — WONDFO RAPID STREP A TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code GTY·2014-01-31
K133655 — RADIANCE V2Gmv Soluciones Globales Internet S.A.U.·Product code MUJ·2014-01-31
K133730 — CO PILOT/REGIUS UNITEAKonica Minolta, Inc.·Product code LLZ·2014-01-31
K133796 — NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),Marvao Medical Devices, Ltd.·Product code MSD·2014-01-31
K133855 — BREEZY ELEGANCESunrise Medical (Us), LLC·Product code IOR·2014-01-31
K133967 — INTERBODY CAGE SYSTEMAurora Spine·Product code MAX·2014-01-31
K134002 — 6MP COLOR LCD MONITOR, RADIFORCE RX650Eizo Corporation·Product code LLZ·2014-01-31
K140012 — SORIN FLEXTHERMSorin Group Deutschland GmbH·Product code DWC·2014-01-31
K130872 — CARDIOCELCelxcel Pty, Ltd.·Product code DXZ·2014-01-30
K131344 — POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVESShijiazhuang Wally Plastics Co., Ltd.·Product code LYZ·2014-01-30
K131833 — CENTURION POCT SYSTEMOrthofix, Inc.·Product code KWP·2014-01-30
K132474 — CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETERAcist Medical Systems·Product code DXO·2014-01-30
K132643 — UV PHOTOTHERAPYXuzhou Kernel Medical Equipment Co., Ltd.·Product code FTC·2014-01-30
K132746 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTIONNobel Biocare USA, LLC·Product code NHA·2014-01-30
K132758 — DIGITAL ELECTROCARDIOGRAPHShenzhen Biocare Bio-Medical Equipment Co., Ltd.·Product code DPS·2014-01-30
K132770 — DOME S10Nds Surgical Imaging·Product code LLZ·2014-01-30
K133184 — ARDIS INTERBODY SYSTEMZimmer Spine, Inc.·Product code MAX·2014-01-30
K133192 — MECTALIF TIPEEKMedacta International·Product code MAX·2014-01-30
K133229 — TITANIUM SUTURE ANCHORMtp Solutions, LLC·Product code MBI·2014-01-30
K133275 — MINI TIGHTROPEArthrex, Inc.·Product code HTN·2014-01-30
K133681 — CRUX SNARE FILTER RETRIEVAL SETVolcano Corporation·Product code MMX·2014-01-30
K140019 — ARTHREX BIOSUTUREArthrex, Inc.·Product code GAT·2014-01-30
DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEMGiven Imaging , Ltd.·Product code PGD·2014-01-29
K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETERCook, Inc.·Product code DQY·2014-01-29
K131444 — UA-CELLULAR COMPLETEStreck·Product code JJW·2014-01-29
K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGERMoor Instruments, Ltd.·Product code DPT·2014-01-29
K132721 — SPIWAY ENDONASAL ACCESS GUIDESpiway, LLC·Product code LYA·2014-01-29
K133176 — AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCALCiba Vision Corporation·Product code LPL·2014-01-29
K133236 — TANDEMHEART FEMORAL VENOUS CANNULA SETCardiacassist, Inc.·Product code DWF·2014-01-29
K133355 — CADWELL FLEX EEG/PSGCadwell Industries, Inc.·Product code GWQ·2014-01-29
DEN130036 — PROSTATE IMMOBILIZER RECTAL BALLOONRadiadyne·Product code PCT·2014-01-28
K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITGold Standard Diagnostics·Product code LJM·2014-01-28
K131413 — XTRAFIX SMALL EXTERNAL FIXATION SYSTEMZimmer, Inc.·Product code KTT·2014-01-28
K133541 — EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEMEmerge Medical·Product code HRS·2014-01-28
K133723 — OTC PATCHWell-Life Healthcare Limited·Product code NUH·2014-01-28
K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSETRoche Diagnostics·Product code CEC·2014-01-27
K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZIbramed Equipamentos Medicos·Product code IMI·2014-01-27
K132444 — ATAMA SYSTEMMonteris Medical,·Product code MOS·2014-01-27
K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics, Inc.·Product code CGX·2014-01-27
K133103 — AVERSION PEDICLE SCREW SYSTEMK7, LLC·Product code MNI·2014-01-27
K133331 — 4D INTEGRATED TREATMENT CONSOLEVarian Medical Systems, Inc.·Product code MUJ·2014-01-27
K133354 — PERI-PROSTHETIC CABLE SYSTEMBiomet, Inc.·Product code JDQ·2014-01-27
K133785 — TRITIUM STERNAL CABLE PLATE SYSTEMPioneer Surgical Technology, Inc.·Product code JDQ·2014-01-27
K133986 — 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAYResonance Innovations, LLC·Product code MOS·2014-01-27
K131307 — ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATORSiemens Healthcare Diagnostics, Inc.·Product code LCP·2014-01-24
K131457 — FETAL ULTRASONIC MONITOR AND ACCESSORIESShenzhen Jumper Medical Equipment Co., Ltd.·Product code KNG·2014-01-24
K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERSAesculap, Inc.·Product code HCH·2014-01-24
K131910 — MPPMarc Pro·Product code NUH·2014-01-24
K132057 — DYNATRON PELTIER THERMOSTIM PROBEDynatronics Corp.·Product code GXY·2014-01-24
K132300 — EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, REApplied Medical Resources Corp.·Product code GEI·2014-01-24
K132616 — EPADSafeop Surgical, Inc.·Product code GWF·2014-01-24
K132782 — CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2Biosense Webster, Inc.·Product code DQK·2014-01-24
K132815 — PUREGRAFT 50 SYSTEMCytori Therapeutics, Inc.·Product code MUU·2014-01-24
K132817 — KIVA VCF TREATMENT SYSTEMBenvenue Medical, Inc.·Product code NDN·2014-01-24
K133013 — INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTEInventis S.R.L.·Product code ETY·2014-01-24
K133259 — YSIO MAXSiemens Medical Solutions USA, Inc.·Product code KPR·2014-01-24
K133602 — ADD-VANTAGE ADDAPTORHospira, Inc.·Product code LHI·2014-01-24
K133642 — RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORKBiophor Diagnostics, Inc.·Product code DJG·2014-01-24
K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODEMegadyne Medical Products, Inc.·Product code GEI·2014-01-24
K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics, Inc.·Product code CGX·2014-01-24
K133881 — MACY CATHETERHospi Corporation·Product code KNT·2014-01-24
K133987 — CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARESBoston Scientific Corporation·Product code FDI·2014-01-24
K140058 — ATRICURE CRYO MODULE SYSTEMAtriCure, Inc.·Product code GEH·2014-01-24
K130666 — KHAN KINETIC TREATMENT (KKT-M2)Optima Health Solutions International Corporation·Product code LXM·2014-01-23
K131490 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.·Product code HSB·2014-01-23
K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8Tosoh Bioscience, Inc.·Product code PDJ·2014-01-23
K132725 — JUVORA DENTQAL DISCJuvora·Product code EBI·2014-01-23
K132841 — ZYNO MEDICAL ADMINISTRATION SETZyno Medical, LLC·Product code FPA·2014-01-23
K132928 — MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGEMedrad, Inc. / Bayer Medical Care, Inc.·Product code DXT·2014-01-23
K132989 — SPEED 808 DIODE LASER SYSTEMBeijing Toplaser Technology Co., Ltd.·Product code GEX·2014-01-23
K133037 — GRINDGUARDGrind Guard Technologies, LLC·Product code OBR·2014-01-23
K133100 — CAREFINE PEN NEEDLEFacet Technologies·Product code FMI·2014-01-23
K133622 — MAC 2000 ECG ANALYSIS SYSTEMWipro GE Healthcare·Product code DPS·2014-01-23
K133675 — AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5Aap Implantate AG·Product code HRS·2014-01-23
K130613 — CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEMLaura Cattabriga·Product code HWC·2014-01-22
K131135 — BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESISBiomet Manufacturing Corp·Product code MBB·2014-01-22
K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE)Dentsply International, Inc.·Product code NHA·2014-01-22
K131837 — CO2 FRACTIONAL LASERBeijing Honkon Technologies Co., Ltd.·Product code GEX·2014-01-22
K132122 — KESTREL POSTERIOR CERVICAL SPINE SYSTEMOmni Surgical, LLC Dba Spine360·Product code KWP·2014-01-22
K132286 — HYPERION LONG PULSED ND: YAG LASERScarlet Rf, Inc.·Product code GEX·2014-01-22
K132421 — AESCULAP PEEK XP SPINAL IMPLANT SYSTEMAesculap Implant Systems, Inc.·Product code MAX·2014-01-22
K132609 — EDS ULTRASONIC TIPSEssential Dental Systems, Inc.·Product code ELC·2014-01-22
K132722 — HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)Instrumentation Laboratory CO·Product code GJS·2014-01-22
K132879 — MPACT EXTENSIONMedacta International·Product code LPH·2014-01-22
K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)Invivo Corporation·Product code LLZ·2014-01-22
K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANTStanmore Implants Worldwide , Ltd.·Product code KRO·2014-01-22

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