FDA 510(k) clearances — page 677

176,637 clearances on record, most recent first.

Clearances — page 677

67,601–67,700 of 176,637

K041652 — ACUPUNCTURE NEEDLESC.A.I. Industries Corp.·Product code MQX·2004-12-29
K042414 — VISIOPLAST ACRYLIC RESINTecres·Product code GXP·2004-12-29
K042705 — DISPOSABLE NON-ADHESIVE SPO2 SENSORSElekon Industries U.S.A., Inc.·Product code DQA·2004-12-29
K042713 — FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5Spine Next America Corporation·Product code MQP·2004-12-29
K042714 — FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4Spine Next America Corporation·Product code MQP·2004-12-29
K042916 — WATCH PAT 100SItamar Medical·Product code MNR·2004-12-29
K042975 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIAmeditech, Inc.·Product code DIS·2004-12-29
K043068 — DIFOTI USB 2.0 SYSTEMElectro-Optical Sciences, Inc.·Product code NTK·2004-12-29
K043162 — PMP4 OXY PROCard Guard Scientific Survival , Ltd.·Product code DQA·2004-12-29
K043167 — PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195XPhamatech, Inc.·Product code JXM·2004-12-29
K043211 — ONLINE DAT BARBITURATES PLUSRoche Diagnostics Corp.·Product code DIS·2004-12-29
K043378 — DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITDrew Scientific , Ltd.·Product code JIT·2004-12-29
K043397 — MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLEBecton, Dickinson & CO·Product code FMI·2004-12-29
K043481 — MODIFICATION TO: ZILVER 635 BILIARY STENTCook, Inc.·Product code FGE·2004-12-29
K043561 — MODIFICATION TO VERTE-STACK SPINAL SYSTEMMedtronic Sofamor Danek·Product code MQP·2004-12-29
K042381 — CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508Acumen Medical, Inc.·Product code DQY·2004-12-28
K042478 — CAPSULE TENSION RING INSERTER, MODEL 7-810Duckworth & Kent, Ltd.·Product code NCE·2004-12-28
K042930 — SPACEVISION CAGE SYSTEMSpine Vision, Inc.·Product code MQP·2004-12-28
K043343 — MODIFICATION TO: CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek·Product code MNH·2004-12-28
K043403 — CEMEX SYSTEM GENTA FAST BONE CEMENTExactech, Inc.·Product code LOD·2004-12-28
K032434 — CLINICAL ELECTRONIC THERMOMETERCotronic Manufacturing·Product code FLL·2004-12-27
K040972 — CALCIUM, AZO DYE REAGENTGenchem, Inc.·Product code CJY·2004-12-27
K040973 — BUN REAGENTGenchem, Inc.·Product code CDS·2004-12-27
K040974 — GLUCOSE OXIDASE, GLUCOSEGenchem, Inc.·Product code CGA·2004-12-27
K040975 — GENCHEM CO2 ACID REAGENTGenchem, Inc.·Product code JFL·2004-12-27
K040976 — GENCHEM CREATININE REAGENTGenchem, Inc.·Product code CGX·2004-12-27
K040977 — GENCHEM ELECTROLYTE BUFFERGenchem, Inc.·Product code JGS·2004-12-27
K042288 — UNICRYLUnited Medical Industries Co. , Ltd.·Product code GAM·2004-12-27
K042329 — SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.·Product code DKJ·2004-12-27
K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12Diagnostic Chemicals , Ltd.·Product code KHS·2004-12-27
K042902 — HERBERT ULNAR HEAD PROSTHESIS SYSTEMStuckenbrock Medizintechnik GmbH·Product code KXE·2004-12-27
K042911 — CEMENTEK LVTeknimed, S.A.·Product code MQV·2004-12-27
K042947 — PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003Arthrocare Corp.·Product code NDN·2004-12-27
K043404 — MODIFICATION TO T2 PROXIMAL HUMERAL NAILHowmedica Osteonics Corp.·Product code HSB·2004-12-27
DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190Roche Molecular Systems, Inc.·Product code NTI·2004-12-23
DEN040012 — AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMAffymetrix, Inc.·Product code NSU·2004-12-23
K030295 — LTU-904 PORTABLE LASER THERAPY UNITRiancorp Pty, Ltd.·Product code NZY·2004-12-23
K040778 — TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)Tanita Corp. of America·Product code MNW·2004-12-23
K041078 — SURGPLAN AND PANPLANImaging Sciences Intl., Inc.·Product code LLZ·2004-12-23
K041757 — FEMSPEC DISPOSABLE VAGINAL SPECULUMFemspec LLC·Product code HIB·2004-12-23
K042038 — MTF ALLOGRAFT ANCHORMusculoskeletal Transplant Foundation·Product code GAT·2004-12-23
K042620 — SONATA 3-D IMAGING ACCESSORY, MODEL 3DSTetrad Corp.·Product code IYO·2004-12-23
K042985 — LIFESTENT NT35 BILIARY STENT SYSTEMEdwards Lifesciences, LLC·Product code FGE·2004-12-23
K043086 — SOMATOM RESPIRATORY GATINGSiemens Medical Solutions USA, Inc.·Product code JAK·2004-12-23
K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSPhonic Ear, Inc.·Product code LZI·2004-12-23
K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279Olympus America, Inc.·Product code CGS·2004-12-23
K043237 — VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACINbioMerieux, Inc.·Product code LON·2004-12-23
K043241 — LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETERAstra Tech, Inc.·Product code GBM·2004-12-23
K043276 — DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULEDatex-Ohmeda·Product code MHX·2004-12-23
K043318 — MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAYRoche Diagnostics Corp.·Product code CGN·2004-12-23
K043381 — INFINIA LIGHTSPEEDGe Medical Systems F.I. Haifa·Product code KPS·2004-12-23
K030400 — NEOSCI MEDICAL ENDOLUMINAL BRUSHNeosci Medical, Inc.·Product code LJS·2004-12-22
K033559 — 12-LEAD GLOVEIneedmd·Product code DRX·2004-12-22
K040971 — GENCHEM ISE ELECTROLYTE REFERENCEGenchem, Inc.·Product code JGS·2004-12-22
K042603 — GYNECARE PROLENE FASTENER SYSTEMETHICON, Inc.·Product code PBQ·2004-12-22
K042631 — EAR THERMOMETER, MODEL WL-320XInnovatech, Inc.·Product code FLL·2004-12-22
K042732 — ARCHITECT CA 15-3 ASSAYFujirebio Diagnostics,Inc.·Product code MOI·2004-12-22
K042760 — PEFAKIT APC-R FACTOR V LEIDEN CONTROLSPentapharm , Ltd.·Product code GGN·2004-12-22
K042762 — PEFAKIT APC-R FACTOR V LEIDENPentapharm , Ltd.·Product code GGW·2004-12-22
K042822 — TCM ENDO V, MODEL 1534NOUVAG AG·Product code EKX·2004-12-22
K042907 — NEEDLE INCAPACITATOR (NEEDLE GUARD)Pdmp, Inc.·Product code FMI·2004-12-22
K042959 — DEPUY C-STEM AMT HIP PROSTHESISDePuy Orthopaedics, Inc.·Product code JDI·2004-12-22
K042982 — QUANTEX MYOGLOBINInstrumentation Laboratory CO·Product code DDR·2004-12-22
K043038 — BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/MLBiotop Technology Co., Ltd.·Product code MEG·2004-12-22
K043056 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIALW. L. Gore & Associates, Inc.·Product code FTL·2004-12-22
K043076 — GE OEC FLUOROSTARGe Oec Medical Systems, Inc.·Product code OWB·2004-12-22
K043081 — GORE POLYPROPYLENE HERNIA MESHW. L. Gore & Associates, Inc.·Product code FTL·2004-12-22
K043158 — ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEMBayer Healthcare, LLC·Product code NBW·2004-12-22
K043184 — HEMOSIL RECOMBIPLASTINInstrumentation Laboratory CO·Product code GJS·2004-12-22
K043239 — HEALTHSTAR ELITEHill Laboratories Co.·Product code ITH·2004-12-22
K043247 — DUCERA ALLCERAMDentsply Intl.·Product code EIH·2004-12-22
K043269 — Lysus Infusion SystemEkos Corp.·Product code QEY·2004-12-22
K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIPKendall·Product code MSD·2004-12-22
K043311 — ASCENSIA ELITE DIABETES CARE SYSTEMBayer Healthcare, LLC·Product code NBW·2004-12-22
K033044 — DREAM CLEANSE S SCALER, DREAM COMPACT S SCALERAmerican Green Dent. Mfg, Inc.·Product code ELC·2004-12-21
K040487 — TRABECULAR METAL KNEE SYSTEM AUGMENTSImplex Corp.·Product code MBH·2004-12-21
K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINERChurchill Medical Systems, Inc.·Product code KPE·2004-12-21
K041810 — SERFAS ENERGY SYSTEMStryker Endoscopy·Product code GEI·2004-12-21
K041850 — MEDALLION MODULAR HIP SYSTEMBiomet Manufacturing, Inc.·Product code LPH·2004-12-21
K041950 — APEX K2 HIP SYSTEMApex Surgical, LLC·Product code LPH·2004-12-21
K042000 — MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMSMsq (M2) , Ltd.·Product code GEX·2004-12-21
K042132 — NOVASYS TRANSURETHRAL RF SYSTEMNovasys Medical, Inc.·Product code NVJ·2004-12-21
K042666 — LUTH-ALL SUB-Q NEEDLE SETLuth-All Medical Products, LLC·Product code FPA·2004-12-21
K042789 — VERTEX RECONSTRUCTION SYSTEMMedtronic Sofamor Danek·Product code KWP·2004-12-21
K042825 — ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEMIntegra LifeSciences Corporation·Product code JXG·2004-12-21
K042841 — M2A/C2A ACETABULAR SYSTEMBiomet, Inc.·Product code JDL·2004-12-21
K042871 — TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3Zimmer Trabecular·Product code LPH·2004-12-21
K042979 — MODIFICATION TO: PLEXALONG SETSPajunk GmbH·Product code BSP·2004-12-21
K043128 — OLYMPUS ENDOARMOlympus Corporation·Product code GWG·2004-12-21
K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETSPajunk GmbH·Product code CAZ·2004-12-21
K043132 — UNIVERSAL XACTTRACEMedcare Flaga·Product code MNR·2004-12-21
K043229 — MODIFICATION TO ALTIUS OCT SYSTEMInterpore Cross Intl.·Product code KWP·2004-12-21
K043232 — UCR SPINAL SYSTEMSeaspine·Product code NKB·2004-12-21
K043280 — MIMIX MP BONE VOID FILLERBiomet, Inc.·Product code GXP·2004-12-21
K043291 — CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884Medtronic Vascular·Product code GEI·2004-12-21
K043452 — TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEMSonosite,Inc.·Product code IYN·2004-12-21
K043455 — SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEMMedison Co., Ltd.·Product code IYN·2004-12-21
K043482 — THE RELIANCE PI PROCESS INDICATOR, MODEL D5116STERIS Corporation·Product code JOJ·2004-12-21
K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.·Product code LKJ·2004-12-20
K042079 — OSS/(SCARF)- AND OSW-SCREWO.M.T. Oberflachen-Und Materialtechnologie GmbH·Product code HWC·2004-12-20

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