FDA 510(k) clearances — page 446

176,542 clearances on record, most recent first.

Clearances — page 446

44,501–44,600 of 176,542

K121449 — DIRECTPATHCybernet Systems Co., Ltd.·Product code LLZ·2012-07-10
K121471 — LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERSLightscalpel, LLC·Product code GEX·2012-07-10
K121807 — V5MS TRANSDUCERSiemens Medical Solutions USA, Inc.·Product code ITX·2012-07-10
K113610 — ANA-SCREEN WITH MDSSBio-Rad Laboratories·Product code LKJ·2012-07-09
K120305 — THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIVThinking Systems Corp.·Product code LLZ·2012-07-09
K120374 — SEVIIN REVERSE SHOULDERIngen Orthopedics, LLC·Product code PHX·2012-07-09
K121407 — OXYBAND WOUND DRESSINGO2s, LLC·Product code FRO·2012-07-09
K121650 — S-SCANEsaote, S.p.A.·Product code LNH·2012-07-09
K112674 — NAVIS TORQUERNavis Medical,Inc·Product code DQX·2012-07-06
K113621 — SMARTDRIVE WHEELCHAIR POWER-ASSISTMax Mobility, LLC·Product code ITI·2012-07-06
K120195 — SAFETY SUBCUTANEOUS TISSUE INFUSION SETMulti Med·Product code FPA·2012-07-06
K120302 — MECHANICAL WHEELCHAIRNovaf Andalucia 2007, SL·Product code IQC·2012-07-06
K120468 — NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTORCook Incorporated·Product code GCJ·2012-07-06
K120582 — HEATLUXHome Skinovations , Ltd.·Product code ILY·2012-07-06
K120649 — AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEMApex BioTechnology Corp.·Product code NBW·2012-07-06
K120726 — FLIGHT 60 VENTILATORFlight Medical Innovations , Ltd.·Product code CBK·2012-07-06
K120807 — SYNTHES MULTILOC HUMERAL NAILING SYSTEMSynthes USA Products, LLC·Product code HSB·2012-07-06
K120937 — SUNFLOWER WARNERAtom Medical Corporation·Product code FMT·2012-07-06
K121030 — SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASESacks Holdings, Inc.·Product code LRX·2012-07-06
K121096 — VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEML&K BIOMED Co., Ltd.·Product code MAX·2012-07-06
K121125 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.·Product code FGE·2012-07-06
K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATESynthes USA·Product code HRS·2012-07-06
K111454 — ILUMINAGE DIODE LASERCynosure, Inc.·Product code OHS·2012-07-05
K112331 — BIOPURE PORTABLE RO SYSTEMSArion Water, Inc.·Product code FIP·2012-07-05
K120138 — BD MAX MRSA ASSAY, BD MAX INSTRUMENTBd Diagnostics (Geneohm Sciences Canada, Inc)·Product code NQX·2012-07-05
K120244 — SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORNexera Medical, Inc.·Product code ONT·2012-07-05
K120338 — ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIAAstra Tech, Inc.·Product code NHA·2012-07-05
K120514 — CARDIOPACSLumedx·Product code LLZ·2012-07-05
K120530 — DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION SDentin Implants Technologies , Ltd.·Product code DZE·2012-07-05
K120636 — SYNAPSE 3D CARDIAC TOOLSFujifilm Medical System U.S.A., Inc.·Product code LLZ·2012-07-05
K120733 — SIMPLANT GOMaterialise Dental NV·Product code LLZ·2012-07-05
K120739 — AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEMTornier, Inc.·Product code PHX·2012-07-05
K121464 — BLUE POWER FREE NITRILE EXAMINATION GLOVENorthstar Healthcare Holdings·Product code LZA·2012-07-05
K121680 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2012-07-05
K121683 — ACCULIF TL CAGECoalign Innovations, Inc.·Product code MAX·2012-07-05
K103577 — TRINON Q & Q3 IMPLANT SYSTEMTrinon Titanium GmbH·Product code DZE·2012-07-03
K112634 — NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.·Product code KPJ·2012-07-03
K113056 — ORANGE COLORED CONDOMS ORANGE SCENTKarex Industries Sdn. Bhd.·Product code HIS·2012-07-03
K113262 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code CHH·2012-07-03
K120177 — SPINAL ELEMENTS CERCLAGE SYSTEMSpinal Elements, Inc.·Product code JDQ·2012-07-03
K120634 — U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEMTaidoc Technology Corporation·Product code DXN·2012-07-03
K120884 — PERICAM PSIPerimed AB·Product code DPT·2012-07-03
K120941 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEMConstant Care, LLC·Product code DRG·2012-07-03
K120966 — DEPUY PULSE LUMBAR CAGE SYSTEMMedos International SARL·Product code MAX·2012-07-03
K121060 — SPINE FRONTIER INDUS ACP SYSTEMSpinefrontier, Inc.·Product code KWQ·2012-07-03
K121107 — FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)Globus Medical, Inc.·Product code MQP·2012-07-03
K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.·Product code DIF·2012-07-03
K121336 — MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000Surgiquest, Inc.·Product code HIF·2012-07-03
K121506 — UTB BLUE POWDER FREE NITRILENorthstar Healthcare Holdings·Product code LZA·2012-07-03
K121629 — COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPRWilliam Cook Europe Aps·Product code DTK·2012-07-03
K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)Cincinnati Sub-Zero Products, Inc.·Product code DWJ·2012-07-03
K121871 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAirstrip Technologies, LP·Product code MWI·2012-07-03
K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann·Product code KHS·2012-07-02
K120285 — K SERIES CPAP SYSTEM WITH HEATED HUMIDIFERCurative Medical, Inc.·Product code BZD·2012-07-02
K121448 — ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHYElekta Inc. D/B/A Nucletron Corporation·Product code MUJ·2012-07-02
K121609 — ASTHMAPOLIS SYSTEMReciprocal Labs Corporation·Product code CAF·2012-07-02
K111785 — FREEDOM(R) STEMMED TIBIAL COMPONENTSMaxx Orthopedics, Inc.·Product code JWH·2012-06-29
K111949 — AC WOUND TREATMENT SYSTEMNanovibronix, Inc.·Product code OMP·2012-06-29
K112318 — CLEARPATH 24Promedic, Inc.·Product code OCX·2012-06-29
K113080 — TUBALGATORMectra Labs, Inc.·Product code HIN·2012-06-29
K113200 — VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAMbioMerieux, Inc.·Product code LON·2012-06-29
K113459 — ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATINGEdwards Lifesciences, LLC·Product code DWF·2012-06-29
K113512 — BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEMBiomet Microfixation·Product code JEY·2012-06-29
K113582 — ARCHSTENT BILIARY SYSTEMOstial Corporation·Product code FGE·2012-06-29
K113767 — MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.·Product code BYJ·2012-06-29
K113775 — FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMOstial Corporation·Product code LOX·2012-06-29
K120193 — ANY VIEW PATIENT MONITORSGuangdong Biolight Meditech Co., Ltd.·Product code MWI·2012-06-29
K120218 — TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)Palm Beach Dental Supply D/B/A Tek USA·Product code EFB·2012-06-29
K120260 — ICTAExcel-Tech Ltd. (Xltek)·Product code OMB·2012-06-29
K120459 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOOscor, Inc.·Product code DYB·2012-06-29
K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICSBrainlab AG·Product code JAI·2012-06-29
K120581 — SC TIP CLEANERNsi·Product code GEI·2012-06-29
K120855 — INTELLISPACE ECGPhilips Health Care·Product code DQK·2012-06-29
K120897 — PROGRIP LAPARSCOPIC SELF-FIXATING MESHSofradim Production·Product code FTL·2012-06-29
K120963 — POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVESMedtexx Manufacturing Sdn. Bhd.·Product code LYY·2012-06-29
K120990 — NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIALZimmer Trabecular Metal Technology·Product code MBH·2012-06-29
K121092 — FLOWEASE [SUBCUTANEOUS] INFUSION SETBaxter Healthcare Corp·Product code FPA·2012-06-29
K121175 — FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CMOstial Corporation·Product code LIT·2012-06-29
K121191 — VERTEX RCCONSTRUCTION SYSTEMMedtronic Sofamor Danek, Inc.·Product code KWP·2012-06-29
K121288 — FUSE CAGEAdvanced Medical Technologies AG·Product code MAX·2012-06-29
K121330 — WAVE O CAGEAdvanced Medical Technologies AG·Product code MAX·2012-06-29
K121332 — LOOP CAGEAdvanced Medical Technologies AG·Product code MAX·2012-06-29
K121333 — WAVE D CAGEAdvanced Medical Technologies AG·Product code MAX·2012-06-29
K121574 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMSynthes, Inc.·Product code JEY·2012-06-29
K121634 — INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORBaxter Healthcare Corporation·Product code FPA·2012-06-29
K121701 — SYSTEMS INTEGRATIONOlympus Medical Systems Corp.·Product code GCJ·2012-06-29
K103467 — CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CMKARL STORZ Endoscopy-America, Inc.·Product code EOB·2012-06-28
K113704 — ARCHITECT HAVAB-GAbbott Laboratories·Product code LOL·2012-06-28
K120375 — MED-RX PATIENT DELIVERY SETBenlan, Inc.·Product code FPA·2012-06-28
K120611 — SONY PVM-2551MD OLED MONITORSony Electronics, Inc.·Product code GCJ·2012-06-28
K120810 — FIBEROPTIC LASER DELIVERY SYSTEMFiberoptic Fabrications, Inc.·Product code GEX·2012-06-28
K120918 — NUVASIVE COROENT TITANIUM SYSTEMNuvasive, Inc.·Product code MAX·2012-06-28
K120996 — FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THINParagon Vision Sciences·Product code HQD·2012-06-28
K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMBayer Healthcare·Product code NBW·2012-06-28
K121527 — WI-FI BODY SCALEShenzhen Healthcare Electronic Technology Co., Ltd.·Product code MNW·2012-06-28
K112686 — NEXT GEN EMG ENDOTRACHEAL TUBEMedtronic Xomed, Inc.·Product code ETN·2012-06-27
K113326 — ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARDOralabs, Inc.·Product code OBR·2012-06-27
K113835 — DATACAPTOR SYSTEMCapsule Tech, Inc.·Product code MWI·2012-06-27
K120243 — GAM-200GC America, Inc.·Product code EMA·2012-06-27
K120371 — DR GREENBURGS HYBRID ACRYLICAlways More Marketing, Inc.·Product code LRK·2012-06-27

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