FDA 510(k) clearances — page 406

176,542 clearances on record, most recent first.

Clearances — page 406

40,501–40,600 of 176,542

K132248 — FLOWER BONE SCREW SETFlower Orthopedics Corporation·Product code HWC·2013-10-30
K132305 — STENTBOOST REL. 4Philips Medical Systems Nederland B.V.·Product code OWB·2013-10-30
K132316 — MULTIVIEWHologic, Inc.·Product code LLZ·2013-10-30
K132357 — SMITH & NEPHEW ULTRATAPESmith & Nephew, Inc.·Product code GAT·2013-10-30
K132796 — SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.·Product code HOZ·2013-10-30
K133122 — IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)Siemens Healthcare Diagnostics, Inc.·Product code JJX·2013-10-30
K123910 — WOUNDWASH SALINE SPRAYNeilmed Pharmaceuticals, Inc.·Product code FRO·2013-10-29
K130048 — REVERSE SHOULDER PROSTHESIS MONOBLOCKEncore Medical L.P.·Product code KWS·2013-10-29
K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.·Product code HOZ·2013-10-29
K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7IeVent Medical, Ltd.·Product code CBK·2013-10-29
K130274 — BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEMElite Surgical Supplies (Pty), Ltd.·Product code MAX·2013-10-29
K131190 — MYPATCHDms-Service, LLC·Product code DSH·2013-10-29
K131867 — 2.5MM INLINE FUSION PLATEBiomet, Inc.·Product code HRS·2013-10-29
K132325 — GUIDOR BIORESORBABLE MATRIX BARRIERSunstar Americas, Inc.·Product code NPK·2013-10-29
K123958 — JIAJIAN POINTOSELECT DIGITALWuxi Jiajian Medical Instrument Co., Ltd.·Product code GZJ·2013-10-28
K131336 — TX WHEELCHAIR CHASSISJcm Seating Solutions, Ltd.·Product code IOR·2013-10-28
K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESIntegra LifeSciences Corporation·Product code DQR·2013-10-28
K132083 — AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35MicroVention, Inc.·Product code KRD·2013-10-28
K132126 — SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEMSpectrum Spine, LLC·Product code MRW·2013-10-28
K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREHitachi Chemical Diagnostics, Inc.·Product code CDN·2013-10-28
K132651 — ITCLAMP 50Innovative Trauma Care, Inc.·Product code DXC·2013-10-28
K132866 — NAUTILUS SPINAL SYSTEMLife Spine, Inc.·Product code NKB·2013-10-28
K132972 — AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACEMedtronic, Inc.·Product code DTN·2013-10-28
K123696 — MEDUSA VASCULAR PLUGEndoshape, Inc.·Product code KRD·2013-10-25
K123713 — IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.·Product code MVM·2013-10-25
K130428 — COVAMESHBiomup S.A.·Product code FTL·2013-10-25
K130459 — TRIA FAN SYSTEMTria Beauty, Inc.·Product code ONG·2013-10-25
K130529 — RAUMEDIC-PTO-MONITORING-SYSTEMRaumedic AG·Product code GWM·2013-10-25
K130866 — BIOLIGHT BIODYNAMBiolight AB·Product code ILY·2013-10-25
K130904 — TRELLIS-8 PERIPHERAL INFUSION SYSTEMCovidien·Product code QEY·2013-10-25
K130999 — OSSEOSPEED PROFILE EVDentsply Implants Manufacturing GmbH·Product code DZE·2013-10-25
K131058 — BIPOLAR FORCEPSBoston Endo-Surgical Technologies, Inc.·Product code GEI·2013-10-25
K131162 — MIRADRY SYSTEMMiramar Labs, Inc.·Product code OUB·2013-10-25
K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERCook, Inc.·Product code LIT·2013-10-25
K132059 — DIAGNOSTIC ULTRASOUND SYSTEMAdvanced Instrumentations, Inc.·Product code IYN·2013-10-25
K132188 — MAMMOGRAPHY VIEWER SMV658Fujifilm Medical System U.S.A., Inc.·Product code LLZ·2013-10-25
K132227 — LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad Laboratories·Product code JJY·2013-10-25
K132809 — INSTINCT ENDOSCOPIC HEMOCLIPWilson-Cook Medical, Inc.·Product code PKL·2013-10-25
K132900 — MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLC·Product code KWP·2013-10-25
K133124 — IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRASiemens Healthcare Diagnostics, Inc.·Product code JJX·2013-10-25
K122295 — CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONSCore 3D Protech, S.L.·Product code NHA·2013-10-24
K131393 — MAK OSS FEMORAL KNEE COMPONENTSBiomet Orthopedics Corp.·Product code KRO·2013-10-24
K131427 — LOTUSSpinal Elements, Inc.·Product code KWP·2013-10-24
K131473 — (QUANTA SYSTEM) SURGICAL LASER FIBERSQuanta System Spa·Product code GEX·2013-10-24
K131881 — OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.·Product code BTI·2013-10-24
K131887 — TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANTChurch & Dwight Co., Inc.·Product code HIS·2013-10-24
K131895 — AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIERFisher & Paykel Healthcare, Ltd.·Product code BTT·2013-10-24
K132255 — ULTRACEMUltradent Products Inc. / Oratech, LLC·Product code EMA·2013-10-24
K132338 — DA01 BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation·Product code NBW·2013-10-24
K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEMBiopro, Inc.·Product code HTN·2013-10-24
K132512 — HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLEEthicon Endo-Surgery, LLC·Product code LFL·2013-10-24
K132556 — SHEATHLESS EAUCATH CORONARY GUIDE CATHETERAsahi Intecc Co., Ltd.·Product code DQY·2013-10-24
K132804 — ACUSON S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro·Product code IYN·2013-10-24
K133003 — RIGHTEST CONTROL SOLUTIONBionime Corporation·Product code JJX·2013-10-24
K130971 — OPTUM TELEHEALTH APPLICATIONOptumhealth Care Solutions, Inc.·Product code DRG·2013-10-23
K131350 — CALIX LUMBAR SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.·Product code MAX·2013-10-23
K131530 — DYNAMESH -CICATFeg Textiltechnik Forschungs-Und Entwicklungsgesel·Product code FTL·2013-10-23
K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBEPhilips Medical Systems·Product code FPD·2013-10-23
K131679 — EVOLUTION MP ADAPTIVE PS TIBIAL INSERTWrightmedicaltechnologyinc·Product code JWH·2013-10-23
K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.·Product code JJY·2013-10-23
K132343 — MARIGEN WOUND DRESSINGKerecis Limited·Product code KGN·2013-10-23
K132446 — RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICESmith & Nephew, Inc.·Product code OMP·2013-10-23
K132493 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGYCovidien, LLC·Product code GDW·2013-10-23
K132502 — VARIAX 2 SYSTEMStryker Trauma AG·Product code HRS·2013-10-23
K132627 — AUTOMATIC DIGITAL BLOOD PRESSURE MONITORHonsun (Nantong) Co., Ltd.·Product code DXN·2013-10-23
K132895 — WMT IMPLANTABLE K-WIREWrightmedicaltechnologyinc·Product code HTY·2013-10-23
K130897 — MEDCOMP VASCU-PICC WITH VALVEMedcomp ( Medical Components)·Product code LJS·2013-10-22
K131157 — RANFAC BONE MARROW ASPIRATION NEEDLERanfac, Corp.·Product code KNW·2013-10-22
K131187 — LESSER METATARSAL HEAD IMPLANT SYSTEMSolana Surgical, LLC·Product code KWD·2013-10-22
K131253 — PERIFLUX 6000Perimed AB·Product code LKD·2013-10-22
K131963 — TAUTONA INJECTOR DEVICETautona Group, LLC·Product code FMF·2013-10-22
K132435 — SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALSSmith & Nephew, Inc.·Product code LZO·2013-10-22
K132494 — VISCOELASTIC INJECTORSight Sciences, Inc.·Product code MRH·2013-10-22
K132673 — 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETERMedtronic, Inc.·Product code DQY·2013-10-22
K132727 — GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Life Technologies, Inc.·Product code MVR·2013-10-22
K132751 — MULTICHEM S PLUS / S PLUS (ASSAYED)Techno-Path Manufacturing , Ltd.·Product code JJY·2013-10-22
K132990 — OCCLUSION BALLOON CATHETERBoston Scientific Corp·Product code MJN·2013-10-22
K133128 — IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATIONSiemens Healthcare Diagnostics, Inc.·Product code JJX·2013-10-22
K130198 — NEO DENTA ZIRCONIANeo Group Limited·Product code EIH·2013-10-21
K130528 — BIOPLEX 2200 APLS IGMBio-Rad Laboratories·Product code MID·2013-10-21
K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLC·Product code LIO·2013-10-21
K132013 — SWIFT AIRResmed, Ltd.·Product code BZD·2013-10-21
K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETEROlympus Surgical Technologies America·Product code EZN·2013-10-21
K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERSBiomet Sports Medicine·Product code MBI·2013-10-18
K122848 — LENSTEC LC INJECTION SYSTEMLenstec, Inc.·Product code MSS·2013-10-18
K130213 — QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELumiquick Diagnostics, Inc.·Product code LDJ·2013-10-18
K130504 — ASA ORAL APPLIANCESAmerican Sleep Association·Product code LRK·2013-10-18
K130684 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems·Product code MKJ·2013-10-18
K131214 — CRANIAL MAP NEUROStryker Corporate·Product code HAW·2013-10-18
K131663 — ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACKEthicon Endo-Surgery, LLC·Product code GDW·2013-10-18
K131859 — MULTIFUNCTIONAL SERIESBeijing Honkon Technologies Co., Ltd.·Product code ONF·2013-10-18
K131947 — PROVOX VEGA PUNCTURE SETAtos Medical AB·Product code EWL·2013-10-18
K131982 — REMSTAR AUTO A-FLEX HTRespironics, Inc.·Product code BZD·2013-10-18
K132096 — RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTORBiophor Diagnostics, Inc.·Product code LDJ·2013-10-18
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche Diagnostics·Product code JHY·2013-10-18
K132947 — DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERSBoston Scientific Corp·Product code KRA·2013-10-18
K123049 — SAPPHIRE INFUSION PUMPQ Core Medical , Ltd.·Product code FRN·2013-10-17
K124041 — NBM-200MPOrsense, Ltd.·Product code DQA·2013-10-17
K130378 — RESPIGUIDE DELIVERY SYSTEMRespicardia·Product code DQY·2013-10-17
K130601 — BIOROOT RCSNovocol, Inc.·Product code KIF·2013-10-17

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