FDA 510(k) clearances — page 442

176,542 clearances on record, most recent first.

Clearances — page 442

44,101–44,200 of 176,542

K113552 — FREEDOM INGUINAL HERNIA IMPLANTInsightra Medical·Product code FTL·2012-08-23
K120004 — (MULTIPLE) DIGITAL THERMOMETERChina Shenyang Med-Land Imp/Exp Corp., Ltd.·Product code FLL·2012-08-23
K120991 — TRANS1 INTERBODY FUSION SYSTEMTrans1 Incorporated·Product code MAX·2012-08-23
K121089 — NMI PICC IIINavilyst Medical, Inc.·Product code LJS·2012-08-23
K121324 — AVT NATURASOFTAdvanced Vision Technologies·Product code LPL·2012-08-23
K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, Inc.·Product code MQN·2012-08-23
K121611 — AMPLATZER TORQVUE FXAga Medical Corporation·Product code DQY·2012-08-23
K121690 — ETCHONIA ZERONA ARMSErchonia Corporation·Product code OLI·2012-08-23
K121695 — ERCHONIA ZERONAErchonia Corporation·Product code OLI·2012-08-23
K121824 — ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2Lascod Spa·Product code ELW·2012-08-23
K122086 — THERMAL LIGATING SHEARSMicroline Surgical, Inc.·Product code GEI·2012-08-23
K122244 — POLARCUP DUAL MOBILITY SYSTEMSmith & Nephew, Inc.·Product code LPH·2012-08-23
K120626 — EON CALCIUM REGENTVital Diagnostics (Manufacturing) Ptyltd·Product code CJY·2012-08-22
K121140 — PROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.·Product code JGS·2012-08-22
K121181 — SWANNSHIDI BONE MARROW ASPIRATION NEEDLEAlliance Partners, LLC·Product code KNW·2012-08-22
K121185 — EDWARDS PERCUTANEOUS SHEATH INTRODUCEREdwards Lifesciences, LLC·Product code DYB·2012-08-22
K121304 — OSTEOMED CRANIAL DISTRACTION SYSTEMOsteomed·Product code PBJ·2012-08-22
K121536 — INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIRSorin Group Italia S.R.L.·Product code DTZ·2012-08-22
K121550 — HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGYEthicon Endo-Surgery, LLC·Product code LFL·2012-08-22
K121854 — SYSTEM, X-RAY, STATIONARYBeijing Sinopharm Hundric Mediline Info. Tech. Co.·Product code KPR·2012-08-22
K121890 — GENESYS PRESSFT SUTURE ANCHORLinvatec Corporation D/B/A Conmed Linvatec·Product code MAI·2012-08-22
K121943 — XPRESS MULTI-SINUS DILATION TOOLEntellus Medical, Inc.·Product code LRC·2012-08-22
K122083 — ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroup·Product code JHW·2012-08-22
K111627 — SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMIdev Technologies, Inc.·Product code FGE·2012-08-21
K111914 — VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEMOlympus America Inc. / Scientific Equipment Group·Product code OEO·2012-08-21
K112916 — TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEMTyson Bioresearch, Inc.·Product code NBW·2012-08-21
K113062 — ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICESEndoservice Optical Instruments GmbH·Product code FBP·2012-08-21
K113312 — HY-CHLO(TM)WOUND SCRUBPatrin Pharma·Product code FQH·2012-08-21
K113568 — MTA-FILLAPEXPaxmed International·Product code KIF·2012-08-21
K120921 — CLEVER CHOICESimple Diagnostics, Inc.·Product code CGA·2012-08-21
K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEMGe Medical System Israel , Ltd.·Product code IYN·2012-08-21
K121485 — GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGHemcon Medical Technologies Europe, Ltd.·Product code QSY·2012-08-21
K121764 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code NKB·2012-08-21
K122240 — BONE PLUS BCP EAGLE EYEMegagen Implant Co., Ltd.·Product code LYC·2012-08-21
K111460 — OPTO HYALUS GREEN LASEROpto Eletronica S/A·Product code HQF·2012-08-20
K120486 — AVS AS PEEK SPACERStryker Spine·Product code ODP·2012-08-20
K120500 — THE PAIN PILOT (A.K.A PAIN PILOT)Hollywog, LLC·Product code NUH·2012-08-20
K120835 — DYNATRON THERMOSTIM PROBE-DONEDynatronics Corporation·Product code GXY·2012-08-20
K121148 — SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM DMedical Design, LLC·Product code HWC·2012-08-20
K121154 — ULTRASONIC NEBULIZERFoshan Gaunying Electronics Co., Ltd.·Product code CAF·2012-08-20
K121452 — GRIDLOCK PLATING SYSTEMTrilliant Surgical, Ltd.·Product code HRS·2012-08-20
K121720 — WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEMWelkins, LLC·Product code DWJ·2012-08-20
K122179 — VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE)Compression Therapy Concepts·Product code JOW·2012-08-20
K112373 — CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATIONInnova Vision, Inc.·Product code LPL·2012-08-17
K113128 — MICROAIRE SURGICAL INSTRUMENTS LLCMicroaire Surgical Instruments, LLC·Product code QPB·2012-08-17
K113715 — LUNG VOLUME ANALYSISToshibamedical Systems Corporation·Product code JAK·2012-08-17
K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)Hitachi Chemical Diagnostics, Inc.·Product code DCN·2012-08-17
K120008 — MEDLINE HIGH PRESSURE INJECTION TUBINGMedline Industries, Inc.·Product code DQO·2012-08-17
K120030 — TAPERLOC COMPLETE SIZE 4MM AND XR 123Biomet Manufacturing Corp·Product code LPH·2012-08-17
K120151 — NEBULAE INorthgate Technologies, Inc.·Product code HIF·2012-08-17
K120890 — POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGEShen Wei (Usa), Inc.·Product code LZA·2012-08-17
K121025 — YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSIONYa Horng Electronic Co., Ltd.·Product code DXN·2012-08-17
K121062 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEMGe Medical System Israel , Ltd.·Product code ITX·2012-08-17
K121176 — STGCCardinal Spine, LLC·Product code MQP·2012-08-17
K121497 — VENOFER PUMPRenal Solutions, Inc.·Product code KDI·2012-08-17
K121718 — A-V FOOT PUMPDalian Labtek Science & Development Co., Ltd.·Product code JOW·2012-08-17
K121910 — OCTAVE SPEEDER HEADToshiba Medical Systems Corporation, Japan·Product code MOS·2012-08-17
K121911 — OCTAVE SPEEDER SPINEToshiba Medical Systems Corporation, Japan·Product code MOS·2012-08-17
K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFTAtrium Medical Corp.·Product code DSY·2012-08-17
K122145 — LANX SPINAL FIXATION SYSTEMLanx, Inc.·Product code NKB·2012-08-17
K122190 — PRELUDE 7F SHORT SHEATH INTRODUCERMerit Medical Systems, Inc.·Product code DYB·2012-08-17
K122203 — TRUETOMEBoston Scientific Corp·Product code KNS·2012-08-17
K120398 — WITOUCH PROHollywog, LLC·Product code GZJ·2012-08-16
K120986 — STRATIFY JCV DXSELECTFocus Diagnostics, Inc.·Product code OYP·2012-08-16
K121095 — DX-D IMAGING PACKAGEAgfa Healthcare N.V.·Product code MQB·2012-08-16
K121173 — CHORD-X EPTFE SUTUREOn-Xlifetechnologies·Product code PAW·2012-08-16
K121422 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEMToshiba Medical Systems Coporation, Japan·Product code IYO·2012-08-16
K121548 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)Spine View, Inc.·Product code HRX·2012-08-16
K121855 — RESPROCESSED SERFAS ENERGY PROBEStryker Sustainability Solutions·Product code NUJ·2012-08-16
K121863 — VITEK 2 AST-ST CEFOTAXIMEbioMerieux, Inc.·Product code LON·2012-08-16
K122182 — DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGCRayence Co., Ltd.·Product code MQB·2012-08-16
K122234 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·Product code OWB·2012-08-16
K122329 — BIOJETJet Soft Srl·Product code LLZ·2012-08-16
K112548 — ALTOMEC ARTHROSCOPEAltomec Endoscopy, Inc.·Product code HRX·2012-08-15
K120902 — GID 700The Gid Group, Inc.·Product code MUU·2012-08-15
K121352 — ARMADA 14XXT PTA CATHETERAbbott Vascular·Product code DQY·2012-08-15
K121615 — 4CIS VANE SPINE SYSTEMSolco Biomedical Co., Ltd.·Product code MNI·2012-08-15
K121727 — MOVATION KNEE SYSTEMEncore Medical L.P.·Product code OIY·2012-08-15
K122036 — VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc.·Product code MWI·2012-08-15
K122070 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 GTrireme Medical, Inc.·Product code LIT·2012-08-15
K122205 — EXINIExini Diagnostics AB·Product code LLZ·2012-08-15
K112362 — C100 WRINKLE REDUCTION DEVICESilver Bay, LLC·Product code OHS·2012-08-14
K113045 — BIOHARNESSZephyr Technology Corporation·Product code MHX·2012-08-14
K120158 — CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSThomas Medical Products, Inc.·Product code DYB·2012-08-14
K120320 — CONNECTED CARE CLINICAL APPLICATIONWatermark Medical, Inc.·Product code DXN·2012-08-14
K120789 — EXACTRAC X-RAY X-RAYBrainlab AG·Product code IYE·2012-08-14
K121334 — VARIOECOThommen Medical AG·Product code NHA·2012-08-14
K121396 — DYNAFLEXDyna Flex·Product code NXC·2012-08-14
K121776 — AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRECodman & Shurtleff, Inc.·Product code DQX·2012-08-14
K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories Limited·Product code JIS·2012-08-14
K122265 — VIALOK SINGLE VIAL ACCESS DEVICE VENTEDYukon Medical, LLC·Product code LHI·2012-08-14
K122285 — TABLET COMMANDERCardiocom, LLC·Product code DRG·2012-08-14
K120152 — CERASORB PLUSRiemser Arzneimittel AG·Product code NPM·2012-08-13
K120446 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2Fujinon, Inc.·Product code FDS·2012-08-13
K120469 — ERISMA-LPClariance·Product code NKB·2012-08-13
K121443 — JOURNEY II CR KNEE SYSTEMSmith & Nephew, Inc.·Product code JWH·2012-08-13
K121667 — NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)Boston Scientific Corp·Product code LOX·2012-08-13
K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERCovalontechnologies, Inc.·Product code FRO·2012-08-13
K122246 — MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12Celleration, Inc.·Product code NRB·2012-08-13
K111246 — SPIRALE DRUG DELIVERY SYSTEMArmstrong Medical , Ltd.·Product code CAF·2012-08-10

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