FDA 510(k) clearances — page 394

176,542 clearances on record, most recent first.

Clearances — page 394

39,301–39,400 of 176,542

K133374 — STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEMPioneer Surgical Technology, Inc. (Rti Surgical, I·Product code KWP·2014-03-19
K133734 — SEAL SINGLE-USE BIOPSY VALVEEndochoice, Inc.·Product code OCX·2014-03-19
K133780 — SPEED XLBiomedical Ent., Inc.·Product code JDR·2014-03-19
K133892 — IVUE 500Optovue, Inc.·Product code HLI·2014-03-19
K140398 — EMBOL-X INTRODUCER SHEATHEdwards Lifesciences, LLC·Product code DYB·2014-03-19
K131210 — ELECTRONIC THERMOMETERShenzhen Pump Medical System Co., Ltd.·Product code FLL·2014-03-18
K132975 — SPHINX JRAllmed Systems, Inc.·Product code GEX·2014-03-18
K133308 — TINNITUS SOUNDSUPPORTOticon A/S·Product code KLW·2014-03-18
K133865 — ASAHI GAIA FIRST, SECOND, THIRDAsahi Intecc Co., Ltd.·Product code DQX·2014-03-18
K133894 — SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)Terumo Europe N.V.·Product code FPA·2014-03-18
K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNIIThe Binding Site·Product code OPX·2014-03-18
K131258 — SATURN DENTAL IMPLANTCortex Dental Implants Industries , Ltd.·Product code DZE·2014-03-17
K133209 — FORESEE (4C) IMAGING SYSTEMDiagnostic Photonics, Inc.·Product code NQQ·2014-03-17
K134054 — BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATORBovie Medical Corporation·Product code GEI·2014-03-17
K131386 — EZ-OX PLUS GENERATION IIAir Liquide Healthcare America·Product code ECX·2014-03-14
K131796 — MANUKA FILL WOUND DRESSINGLinks Medical Products, Inc.·Product code FRO·2014-03-14
K131899 — SW-THERMShenzhen Dongdixin Technology Co., Ltd.·Product code IMJ·2014-03-14
K131928 — FREND TSH (REAGENT CARTRIDGE)Nanoentek USA, Inc.·Product code JLW·2014-03-14
K132393 — CERCOM II CEMENTDenali Corporation·Product code EMA·2014-03-14
K132698 — FASTOUCH FIXATION SYSTEMVia Surgical , Ltd.·Product code GDW·2014-03-14
K132805 — BG MORSELSProsidyan, Inc.·Product code MQV·2014-03-14
K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATIONGe Hungary Kft·Product code KPQ·2014-03-14
K133227 — SMART SEGMENTATION - KNOWLEDGE BASED CONTOURINGVarian Medical Systems, Inc.·Product code IYE·2014-03-14
K133252 — HEALTHINTERLINK BEACONHealthinterlink, LLC·Product code DRG·2014-03-14
K133323 — VOLCANO IFR MODALITYVolcano Corporation·Product code IYO·2014-03-14
K133406 — CS 8100 3DTrophy·Product code OAS·2014-03-14
K133410 — DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SETDiazyme Laboratories·Product code MRG·2014-03-14
K133608 — TRINIABicon, LLC·Product code EBF·2014-03-14
K133824 — CERASMARTGC America, Inc.·Product code EBF·2014-03-14
K133893 — STERISPINE LC CAGESafe Orthopaedics·Product code MAX·2014-03-14
K134052 — RADIANCE 330 PROTON THERAPY SYSTEMProtom International, Inc.·Product code LHN·2014-03-14
K140345 — THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)C.R. Bard, Inc.·Product code LJS·2014-03-14
K140388 — LUMENIS PULSE 120HLumenis, Ltd.·Product code GEX·2014-03-14
K130501 — INTENSIFEndymed Medical, Ltd.·Product code OUH·2014-03-13
K132752 — ULTRACONGRUENT INSERTUnited Orthopedic Corporation·Product code JWH·2014-03-13
K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAYInstrumentation Laboratory CO·Product code GGP·2014-03-13
K133015 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.·Product code KCT·2014-03-13
K133097 — E-Z LINKDuoject Medical Systems, Inc.·Product code LHI·2014-03-13
K133205 — CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2014-03-13
K133221 — ARSENAL SPINAL FIXATION SYSTEMAlphatec Spine, Inc.·Product code NKB·2014-03-13
K133381 — OMNI ARC MONOBLOCK HIP STEMOmnilife Science·Product code LZO·2014-03-13
K133665 — MALLEABLE SUCTION INSTRUMENTSMedtronic Navigation, Inc.·Product code PGW·2014-03-13
K133764 — CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIALAvery Dennison Belgie Bvba·Product code FRO·2014-03-13
K133832 — KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUSTotal Joint Orthopedics, Inc.·Product code LPH·2014-03-13
K140107 — EMERGE MEDICAL DISTAL RADIUS SETEmerge Medical·Product code HRS·2014-03-13
K140276 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek·Product code OSH·2014-03-13
K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEMCordis Corp.·Product code FGE·2014-03-12
K131675 — BODIHEALTH SYSTEMEprt Technologies, Inc.·Product code GZJ·2014-03-12
K132080 — SNAP WOUND CARE SYSTEMSpiracur, Inc.·Product code OKO·2014-03-12
K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEMBausch & Lomb·Product code HQC·2014-03-12
K133746 — POLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code NKB·2014-03-12
K140064 — SURGISLEEVE WOUND PROTECTORCovidien·Product code KKX·2014-03-12
K140098 — EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEMEmerge Medical·Product code HRS·2014-03-12
K140119 — EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEMEmerge Medical·Product code HRS·2014-03-12
K140318 — SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETERBiosense Webster·Product code OBJ·2014-03-12
K140405 — TORRENT IRRIGATION SYSTEMUnited States Endoscopy Group, Inc.·Product code OCX·2014-03-12
DEN120019 — CEFALYStx-Med Sprl·Product code PCC·2014-03-11
K122358 — NOVEONHogan Lovells US LLP·Product code GEX·2014-03-11
K131433 — ISYS 1 (U.S),ACCESSORY, NON-STERILEIsys Medizintechnik GmbH·Product code JAK·2014-03-11
K131916 — BPROSOFT CASP PC SOFTWAREHealthstats International Pte. , Ltd.·Product code DXN·2014-03-11
K132094 — CIOS ALPHASiemens Medi Cal Solutions, Inc.·Product code OWB·2014-03-11
K132322 — NEWTRON P5 XS B.LEDSatelec - Acteon Group·Product code ELC·2014-03-11
K132736 — ACCURO 3000 ULTRASOUND SCANNERRivanna Medical, LLC·Product code IYO·2014-03-11
K133350 — REVERE STABILIZATION SYSTEMGlobus Medical, Inc.·Product code NKB·2014-03-11
K133386 — OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEMOrtho Development Corp.·Product code LPH·2014-03-11
K133401 — SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERALSiemens Medical Solutions USA, Inc.·Product code LLZ·2014-03-11
K133442 — BONE SUPPRESSION SOFTWARECarestream Health, Inc.·Product code MQB·2014-03-11
K133483 — PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USEPortable Therapeutix·Product code IRP·2014-03-11
K133755 — KOWA SL-17Kowa Co. , Ltd.·Product code HJO·2014-03-11
K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)Hitachi Chemical Diagnostics, Inc.·Product code KHS·2014-03-11
K140327 — ULTIMUM EV HEMOSTASIS INTRODUCERSt Jude Medical·Product code DYB·2014-03-11
K121123 — BIOFUSIONARY BEBERocky Mountain Biosystems, Inc.·Product code IMJ·2014-03-10
K121664 — T4/T5 HYTREL TOGASStryker Corporation·Product code FYA·2014-03-10
K123276 — MM-SEALMicro-Mega Societe Anonyme·Product code KIF·2014-03-10
K131708 — BWCSH-1 SHARPS CONTAINERBradford Wright Companies, Inc.·Product code MMK·2014-03-10
K132267 — NEWTRON P5, NEWTRON P5 B.LEDSatelec - Acteon Group·Product code ELC·2014-03-10
K132959 — DEPUY PINNACLE ALTRX ACETABULAR LINERSDePuy Orthopaedics, Inc.·Product code LPH·2014-03-10
K133104 — VAN HIP FRACTURE SYSTEMEpix Orthopaedic, Corp.·Product code HSB·2014-03-10
K133196 — IMPACT MODEL 323 ASPIRATORImpact Instrumentation, Inc.·Product code JCX·2014-03-10
K133469 — ACUMED SUTURE ANCHOR SYSTEMAcumed, LLC·Product code MBI·2014-03-10
K133864 — DERMABOND PRINEO SKIN CLOSURE SYSTEMETHICON, Inc.·Product code OMD·2014-03-10
K140267 — ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)Siemens Healthcare Diagnostics, Inc.·Product code JJX·2014-03-10
K140328 — CMC MINI TIGHTROPEArthrex, Inc.·Product code HTN·2014-03-10
K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG·Product code HLJ·2014-03-07
K132107 — MALE LATEX CONDOMNulatex Sdn. Bhd.·Product code HIS·2014-03-07
K132945 — CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAILI.T.S. GmbH·Product code HSB·2014-03-07
K133135 — IMPAX VOLUME VIEWING 3.0Agfa Healthcare N.V.·Product code LLZ·2014-03-07
K133214 — BLACKBIRD SPINAL SYSTEMChoicespine, LP·Product code KWP·2014-03-07
K133363 — INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEMLdr Spine USA, Inc.·Product code PEK·2014-03-07
K133436 — FLASH AR; FLASH AR QUICK3M Deutschland GmbH·Product code ELW·2014-03-07
K133527 — SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHTOsstem Germany GmbH·Product code ELW·2014-03-07
K133713 — CHARLOTTE (TM) SNAP-OFF SCREWWrightmedicaltechnologyinc·Product code HWC·2014-03-07
K134026 — ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNITOlympus Medical Systems Corp.·Product code PGU·2014-03-07
K140093 — TABLEAnatomage, Inc.·Product code LLZ·2014-03-07
K140148 — PRO-TOE HAMMERTOE FIXATION SYSTEMWrightmedicaltechnologyinc·Product code HWC·2014-03-07
K140286 — OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETERCordis, A Johnson & Johnson Co.·Product code DTK·2014-03-07
K140291 — VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMSVolcano Corporation·Product code IYO·2014-03-07
K140323 — NAVIGATOR HD URETERAL ACCESS SHEATH SETSBoston Scientific·Product code FED·2014-03-07
K131506 — AIRWAY SUPPORT SYSTEM / AIRPORTAbeon Medical Corporation·Product code CCK·2014-03-06
K131562 — BREATHE NIOV VENTILATION SYSTEMBreathe Technologies·Product code ONZ·2014-03-06

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