FDA 510(k) clearances — page 435

176,542 clearances on record, most recent first.

Clearances — page 435

43,401–43,500 of 176,542

K113113 — ENDOSSEOUS DENTAL IMPLANTOt Medical GmbH·Product code DZE·2012-11-16
K113344 — STEREOS WORKSTATIONEos Imaging·Product code LLZ·2012-11-16
K120066 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIALKossan Latex Industries(M)Sdn Bhd·Product code LZA·2012-11-16
K121151 — PRO-LINK CERVICAL SPACER SYSTEMLife Spine, Inc.·Product code OVE·2012-11-16
K121225 — HAMILTON-C2Hamilton Medical AG·Product code CBK·2012-11-16
K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd.·Product code JAK·2012-11-16
K122008 — INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICEIncite Innovation, LLC·Product code OVE·2012-11-16
K122129 — SPHYGMOCOR XCELAtcor Medical·Product code DXN·2012-11-16
K122171 — MS SA IMPLANT SYSTEMOsstem Implant Co., Ltd.·Product code DZE·2012-11-16
K122174 — PEDIATRIC POSITIONER PAD SETGe Healthcare Coils (Usa Instruments, Inc.)·Product code KXH·2012-11-16
K122236 — VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADERVarian Medical Systems, Inc.·Product code JAQ·2012-11-16
K122526 — 360 GAS ASSISTED ENDOSCOPIC APPLICATORMicromedics, Inc.·Product code GCJ·2012-11-16
K122529 — ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACEZimmer, Inc.·Product code HSX·2012-11-16
K122686 — ACCU-CHEK ULTRAFLEX INFUSION SETRoche Diabetes Care AG·Product code FPA·2012-11-16
K122729 — ABL90 FLEXRadiometer Medical Aps·Product code CHL·2012-11-16
K123026 — TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRONorthstar Healthcare Holdings·Product code LYY·2012-11-16
K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWERGE Healthcare·Product code LLZ·2012-11-16
K123246 — CD HORIZON SPIRE Z SPINAL SYSTEMMedtronic Sofamor Danek·Product code NKB·2012-11-16
K113380 — PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATORMedtronic, Inc.·Product code GEI·2012-11-15
K113728 — SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.·Product code MBP·2012-11-15
K121857 — FEMMYCYCLEFemcap Incorporated·Product code HHE·2012-11-15
K122011 — NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAPBrainlab AG·Product code OLO·2012-11-15
K122090 — SJM CONFIRM IMPLANTABLE CARDIAC MONITORSt. Jude Medical, Cardiac Rhythm Management Divisi·Product code MXC·2012-11-15
K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSINGHemostasis, LLC·Product code QSY·2012-11-15
K122899 — POWERPORT CLEARVUE SLIM IMPLANTABLE PORTC.R. Bard, Inc.·Product code LJT·2012-11-15
K122904 — WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CUGuangzhou Wondfo Biotech Co., Ltd.·Product code DKZ·2012-11-15
K123259 — MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEMDevicor Medical Products, Inc.·Product code KNW·2012-11-15
K122860 — KLS MARTIN RECON TALONKLS Martin L.P.·Product code HRS·2012-11-14
K112830 — ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)Noninvasive Medical Technologies, Inc.·Product code DSB·2012-11-13
K120857 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXNcontact Surgical, Inc.·Product code OCL·2012-11-13
K122180 — HIGH FLOW INSUFFLANTION UNITOlympus Medical Systems Corporation·Product code HIF·2012-11-13
K122324 — VPAP S-AResmed, Ltd.·Product code MNS·2012-11-13
K122662 — VERTIFLEX DIRECT DECOMPRESSION SYSTEMVertiflex, Inc.·Product code HRX·2012-11-13
K123056 — PASCAL LASER INDIRECT OPHTHALMOSCOPETopcon Medical Laser Systems, Inc. (Tmls)·Product code HQF·2012-11-13
K123068 — OPTIMA MR 430SGe Medical Systems, LLC·Product code LNH·2012-11-13
K123214 — ENCORE 26 ADVANTAGE KITBoston Scientific Corp·Product code MAV·2012-11-13
K112091 — H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADSLima Corporate S.P.A.·Product code MEH·2012-11-09
K112853 — VOLTERA POWERED SUCTION PUMPSuzric Enterprise Co., Ltd.·Product code OMP·2012-11-09
K113124 — ALN OPTIONAL VANA CAVA FILTERAln Implants Chirurgicaux·Product code DTK·2012-11-09
K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.·Product code LFR·2012-11-09
K120888 — PSG-1100 SLEEP DIAGNOSTIC SYSTEMNihon Kohden Corp.·Product code GWQ·2012-11-09
K121354 — MICRO/MINI N-PK(F) BONE ANCHORAnulex Technologies, Inc.·Product code MBI·2012-11-09
K121356 — MICRO/MINI N-PK(H) BONE ANCHORAnulex Technologies, Inc.·Product code MBI·2012-11-09
K121599 — CRIT-LINE CLIP (CLIC)Fresenius Medical Care-North America·Product code KOC·2012-11-09
K121891 — NEWPORT AURA VENTILATORNewport Medical Instruments, Inc.·Product code CBK·2012-11-09
K122122 — REGEN SPRAY APPLICATOR,Regen Lab SA·Product code FMF·2012-11-09
K122405 — AIR-BAND RADIAL COMPRESSION DEVICEDatascope Corp., Cardiac Assist Division·Product code DXC·2012-11-09
K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIESEncision, Inc.·Product code GEI·2012-11-09
K122765 — PERSONA NATURAL TIBIA BASEPLATESZimmer, Inc.·Product code JWH·2012-11-09
K113066 — CORVIS STOculus Optikgerate GmbH·Product code HKX·2012-11-08
K113316 — DCS LACRIMAL STENTDcs Surgical, Inc.·Product code OKS·2012-11-08
K113601 — AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEMAap Implantate AG·Product code HRS·2012-11-08
K120479 — MTF FASCIAMusculoskeletal Transplant Foundation·Product code OWY·2012-11-08
K120873 — ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEMZimmer Dental, Inc.·Product code NHA·2012-11-08
K121607 — TERUMO(R) NEEDLETerumo (Philippines) Corporation·Product code FMI·2012-11-08
K122795 — STINGRAY GUIDEWIRESBridgepoint Medical·Product code DQX·2012-11-08
K112877 — COMEN MULTI-PARAMETER PATIENT MONITORGoldway (Us), Inc.·Product code MWI·2012-11-07
K120508 — CLEARLUMEN THROMBECTOMY SYSTEMWalk Vascular, LLC·Product code QEZ·2012-11-07
K121277 — Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLEZ-Medical GmbH & Co. KG·Product code HWC·2012-11-07
K121725 — PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEMPioneer Surgical Technology, Inc.·Product code KWP·2012-11-07
K121771 — ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.·Product code MBH·2012-11-07
K121814 — ENCORE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.·Product code ORY·2012-11-07
K122278 — BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATORBaylis Medical Company, Inc.·Product code GEI·2012-11-07
K122380 — OCELOT SYSTEMAvinger, Inc.·Product code PDU·2012-11-07
K122689 — INOBLENDERIno Therapeutics·Product code MRO·2012-11-07
K122738 — GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SETSolana Surgical, LLC·Product code HWC·2012-11-07
K122857 — HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100Pegasus Research Corp.·Product code CAF·2012-11-07
K122912 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)Hangzhou Hua'An Medical & Health Instruments Co.,·Product code FLL·2012-11-07
K122959 — HAMMER TOE IMPLANTTrilliant Surgical, Ltd.·Product code HWC·2012-11-07
K123268 — SMARTSTITCH PERFECTPASSER SYSTEMArthocare Corporation·Product code GAT·2012-11-07
K112599 — INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLC·Product code KIJ·2012-11-06
K113225 — NYLUS PICCSemprus Biosciences·Product code LJS·2012-11-06
K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)Nanosphere, Inc.·Product code NTI·2012-11-06
K120560 — TRINITY WRINKLE REMOVERCarol Cole Company·Product code OHS·2012-11-06
K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGEHu-Friedy Mfg. Co., LLC·Product code EJI·2012-11-06
K122187 — VRESELECT CULTURE MEDIUMBio-Rad·Product code JSO·2012-11-06
K122998 — BLUE POWDERED NITRILE EXAMINATION GLOVENorthstar Healthcare Holdings·Product code LZA·2012-11-06
K120280 — RELIEVA SEEKER BALLOON SINUPLASTY SYSTEMAcclarent, Inc.·Product code LRC·2012-11-05
K121434 — SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIOSiemens Medi Cal Solutions, Inc.·Product code LNH·2012-11-05
K121509 — TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERTTgm Medical, Inc.·Product code KWY·2012-11-05
K121562 — ALTIS SINGLE INCISION CLING SYSTEMColoplast A/S·Product code PAH·2012-11-05
K121692 — MINIME 2 NASAL MASKSleepnet Corporation·Product code BZD·2012-11-05
K121786 — DYMAXEON SPINE SYSTEMB2b Spine Pty, Ltd.·Product code NKB·2012-11-05
K121858 — THE ABLATION SYSTEMHalt Medical, Inc.·Product code HFG·2012-11-05
K122058 — FLEXIPORT ECOCUFFWelch Allyn, Inc.·Product code DXQ·2012-11-05
K122425 — VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECTDepuy Mitek, A Johnson & Johnson Company·Product code GEI·2012-11-05
K122512 — CS2 HIP SYSTEMConsensus Orthopedics, Inc.·Product code LPH·2012-11-05
K123182 — OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC·Product code GNX·2012-11-05
K112396 — IUI CATHETERSKitazato Medical Co., Ltd.·Product code MQF·2012-11-02
K112735 — TAMARIN BLUE PTCA RX DILATATION CATHETERNatec Medical , Ltd.·Product code LOX·2012-11-02
K120555 — LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)Medical-Latex (Dua) Sdn. Bhd·Product code HIS·2012-11-02
K120642 — RESUSCITAIRE WITH AUTOBREATHDraeger Medical Systems, Inc.·Product code FMT·2012-11-02
K120909 — EC 2.7 ENDOSCOPIC CUTTERMedtronic Advanced Energy, LLC·Product code GEI·2012-11-02
K121026 — FLO-GUARD BREATHING FILTERIntersurgical, Inc.·Product code CAH·2012-11-02
K121200 — FLIGHTPLAN FOR LIVERGE Healthcare·Product code LLZ·2012-11-02
K121213 — VITREAADVANCEDVital Images, Inc.·Product code LLZ·2012-11-02
K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)Cepheid·Product code NJR·2012-11-02
K121878 — CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBESMedtronic, Inc.·Product code OCL·2012-11-02
K122192 — NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEMStraumann USA, LLC·Product code NHA·2012-11-02
K122367 — BARD PTV DILATATION CATHETERC.R. Bard, Inc.·Product code OMZ·2012-11-02

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