FDA 510(k) clearances — page 471

176,542 clearances on record, most recent first.

Clearances — page 471

47,001–47,100 of 176,542

K111916 — CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code HSX·2011-09-29
K111943 — AGILLS PF DELIVERY SYSTEMSt. Jude Medical, Cardiac Rhythm Management Divisi·Product code DYB·2011-09-29
K112131 — NEODYNE DRESSINGNeodyne Biosciences, Inc.·Product code MDA·2011-09-29
K112136 — TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPEKunshan Jiehong Nonwoven Product Co., Ltd.·Product code KKX·2011-09-29
K112226 — HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc.·Product code HCG·2011-09-29
K112434 — BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTIONBd Medical Surgical·Product code KNT·2011-09-29
K112525 — D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERSParexel International·Product code DTM·2011-09-29
K112584 — 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERTIntuitive Surgical, Inc.·Product code NAY·2011-09-29
K103217 — LITE-MED LM-9200 ELMALite-Med, Inc.·Product code LNS·2011-09-28
K111475 — AURIGA XLStarmedtec GmbH·Product code GEX·2011-09-28
K111553 — SPINEFRONTIER LUMBAR IBF SYSTEMSpinefrontier, Inc.·Product code MAX·2011-09-28
K112477 — PALINDROME H, SI, HSI CHRONIC CATHETERCovidien·Product code NYU·2011-09-28
K112496 — PIONEER CROSSFUSE II IBF/VBR SYSTEMPioneer Surgical Technology, Inc.·Product code MAX·2011-09-28
K112556 — ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTSHowmedica Osteonics Corp.·Product code MEH·2011-09-28
K103396 — COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTIONI-Sens, Inc.·Product code NBW·2011-09-27
K110290 — EXETER HIP STEMHowmedica Osteonics Corp.·Product code JDI·2011-09-27
K110673 — HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNERHitachi Medical Systems America, Inc.·Product code IYN·2011-09-27
K110800 — META-LOCK SUTURE ANCHOR SYSTEMTarsus Medical, Inc.·Product code MBI·2011-09-27
K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.·Product code LBS·2011-09-27
K111697 — AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEMAbbott Medical Optics, Inc.·Product code HQC·2011-09-27
K111837 — RADIAL ARTERY COMPRESSION TOURNIQUETLepu Medical Technology (Beijing) Co., Ltd.·Product code DXC·2011-09-27
K111951 — ISOAMP HSV ASSAYBiohelix Corporation·Product code OQO·2011-09-27
K112129 — VITEK(R) 2 STREPTOCOCCUS CLINDAMYCINbioMerieux, Inc.·Product code LON·2011-09-27
K112371 — LOGIQ P3GE Healthcare·Product code IYN·2011-09-27
K112555 — CD HORIZON(R) SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2011-09-27
K112726 — SONIX ULTRASOUND SCANNERUltrasonix Medical Corporation·Product code IYN·2011-09-27
K110462 — KEPLER MEDTEC DISPOSABLE BIPOLAR CABLEKepler Medtec·Product code GEI·2011-09-26
K110497 — PASS LP SPINAL SYSTEMMedicrea International·Product code MNH·2011-09-26
K111287 — ASTRA TECH IMPLANT SYSTEMAstra Tech AB·Product code DZE·2011-09-26
K111496 — 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITORTotoku Electric Co., Ltd.·Product code LLZ·2011-09-26
K111614 — CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CAREGe Healthcare Integrated IT Solutions·Product code HGM·2011-09-26
K111641 — SURGICASE ORTHOGNATHIC SOFTWARE WIZARDMaterialise NV·Product code LLZ·2011-09-26
K111809 — SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWSBiomaterials Korea, Inc.·Product code OAT·2011-09-26
K111838 — INQU PASTE MIXIsto Technologies, Inc.·Product code MQV·2011-09-26
K111839 — SELECTRA ACCESSORY KITBiotronik, Inc.·Product code DQY·2011-09-26
K111845 — THE ESPINER SAC OR E SACEspiner Medical Limited·Product code GCJ·2011-09-26
K111880 — SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICESpineology, Inc.·Product code MAX·2011-09-26
K111946 — TEPHAFLEX MESHTepha, Inc.·Product code OOD·2011-09-26
K112232 — REPROCESSED ELECTROPHYSIOLOGY CATHETERSStryker Sustainability Solutions·Product code NLH·2011-09-26
K112482 — SELECTRA SLITTER TOOLBiotronik, Inc.·Product code DQY·2011-09-26
K112524 — HAIRMAX LASERCOMBLexington International, LLC·Product code OAP·2011-09-26
K102938 — ACQPOINT THERMAJADE MASSAGE TABLEAcqpoint, Inc.·Product code JFB·2011-09-23
K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASKKimberly-Clark·Product code OXZ·2011-09-23
K110572 — MAMMODIAGNOST DRPhilips Medical Systems·Product code MUE·2011-09-23
K110878 — RHYTHMVIEW (TM)Topera, Inc.·Product code DQK·2011-09-23
K110913 — ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORYEndoscopic Technologies, Inc. D/B/A Estech·Product code OCL·2011-09-23
K111361 — PLANMED NUANCE EXCELPlanmeca USA, Inc.·Product code MUE·2011-09-23
K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAWCoreleader Biotech Co., Ltd.·Product code FRO·2011-09-23
K111649 — CS 7600Carestream Health, Inc.·Product code MUH·2011-09-23
K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEMGamma Medica-Ideas Incorporated·Product code IYX·2011-09-23
K111888 — MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSMasimo Corporation·Product code DQA·2011-09-23
K112071 — WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-PGuangzhou Wondfo Biotech Co., Ltd.·Product code DIO·2011-09-23
K112122 — VENUE 40GE Healthcare·Product code IYN·2011-09-23
K112463 — UNITED 36MM CERAMIC FEMORAL HEAD, DELTAUnited Orthopedic Corporation·Product code LZO·2011-09-23
K112474 — CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARECedars-Sinai Medical Center·Product code KPS·2011-09-23
K112517 — ULTRASEAL XT HYDROUltradent Products, Inc.·Product code EBC·2011-09-23
K110583 — SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.·Product code LRG·2011-09-22
K111069 — OSTEOSYMBIONICS, ST TEMPORALIS IMPLANTOsteosymbionics, LLC·Product code MNF·2011-09-22
K111733 — CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.·Product code MDA·2011-09-22
K111797 — 27 G X 1/2 K-PACK SURSHIELD NEEDLETerumo Europe N.V.·Product code FMI·2011-09-22
K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLERAdvanced Instrumentations, Inc.·Product code KNG·2011-09-22
K111989 — CORONIS FUSION 4MP DLBarco N.V.·Product code LLZ·2011-09-22
K112022 — DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMAdvanced Instrumentations, Inc.·Product code IYO·2011-09-22
K112347 — RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGEVascular Pathways, Inc.·Product code FOZ·2011-09-22
K112431 — DIGITAL ELECTROCARDIOGRAPHShenzhen Biocare Electronics Co., Ltd.·Product code DPS·2011-09-22
K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENTRhythmlink International, LLC·Product code ETN·2011-09-22
K112448 — PULSIOFLEXPulsion Medical Systems, Inc.·Product code DXG·2011-09-22
K112455 — AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATESHowmedica Osteonics Corp., Dba Stryker Orthopaedics·Product code HRS·2011-09-22
K112645 — RADIFORCE LARGE MONITOR SYSTEMEizo GmbH·Product code DXJ·2011-09-22
K101299 — ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics·Product code LFR·2011-09-21
K110061 — CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIALSiemens Healthcare Diagnostics·Product code JJX·2011-09-21
K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEMU. S. Diagnostics, Inc.·Product code NBW·2011-09-21
K110914 — TRIPLE LUMEN PFM PICCPfm Medical, Inc.·Product code LJS·2011-09-21
K111370 — ODALYS PEDICLE SCREW SYSTEMKalitec Direct, LLC·Product code MNH·2011-09-21
K111833 — VIRTUEDiagnosoft, Inc.·Product code LLZ·2011-09-21
K111857 — SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREEInmed Gloves Factory·Product code LYZ·2011-09-21
K111868 — STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATINGCardinal Health-Medical Products and Services·Product code KGO·2011-09-21
K111876 — Z BOND, PRELUDE ONEDanville Materials, Inc.·Product code KLE·2011-09-21
K111936 — ORTHO DEVLOPMENT CERAMIC FEMORAL HEADOrtho Development·Product code LZO·2011-09-21
K111973 — VAGINAL CT / MR MULTI CHANNEL APPLICATOR SETNucletron·Product code JAQ·2011-09-21
K112159 — CMS-1000FM CENTRAL MONITORING SYSTEMAdvanced Instrumentations, Inc.·Product code HGM·2011-09-21
K112187 — FM-1000 PLUS FETAL MONITORAdvanced Instrumentations, Inc.·Product code HGM·2011-09-21
K101185 — NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAYIris Molecular Diagnostics·Product code OWM·2011-09-20
K101356 — Spacer-G and Spacer-KTecres S.P.A.·Product code KWL·2011-09-20
K110493 — TANDEMHEART PUMPCardiacassist, Inc.·Product code KFM·2011-09-20
K111223 — AMSCO CHIMERON SMALL STEAM STERILIZERSTERIS Corporation·Product code FLE·2011-09-20
K111279 — NEXWAVE COMBO MUSCLE STIMULATOR SYSTEMZynex Medical, Inc.·Product code IPF·2011-09-20
K111451 — MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XXMicroVention, Inc.·Product code HCG·2011-09-20
K111576 — NT 2000 LESIONING GENERATORNeuro Therm, Inc.·Product code GXD·2011-09-20
K111710 — FULL AUTO TONOMETER MODEL TX-20Canon Inc. -Medical Equipment Group·Product code HKX·2011-09-20
K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)Sorin Group Deutschland GmbH·Product code DWA·2011-09-20
K112253 — CERALAS 147NM DIODE LASER SYSTEMBiolitec, Inc.·Product code GEX·2011-09-20
K112257 — BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEMolnlycke Health Care Us, LLC·Product code KGO·2011-09-20
K103290 — EDLEN IMAGING - GEMINI DUSBEdlen Imaging, LLC·Product code MUH·2011-09-19
K111174 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·Product code FKR·2011-09-19
K111912 — MOBILETT MIRASiemens Medical Solutions USA, Inc.·Product code IZL·2011-09-19
K112236 — WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code LAF·2011-09-19
K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSEBionostics, Inc.·Product code JJX·2011-09-19
K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000Hill-Rom Co.·Product code INK·2011-09-19
K100806 — DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUMDelbio Incorporation·Product code NBW·2011-09-16

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