FDA 510(k) clearances — page 519

176,542 clearances on record, most recent first.

Clearances — page 519

51,801–51,900 of 176,542

K100290 — ESTEMP NESpident Co., Ltd.·Product code EMA·2010-02-17
K091234 — SKELTEX ISVSkeltex Technologies, Inc.·Product code NDN·2010-02-16
K092805 — COLLAGEN SPONGEInnocoll Pharmaceuticals·Product code KGN·2010-02-16
K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.·Product code HIB·2010-02-16
K093329 — SCOPE INTRODUCER MODEL 7400N.M. Beale Co., Inc.·Product code ODC·2010-02-16
K093515 — 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LONBrivant, Ltd.·Product code DQX·2010-02-16
K093544 — TROPAZONE CRMidlothian Laboratories·Product code FRO·2010-02-16
K093824 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BTHealth & Life Co., Ltd.·Product code DXN·2010-02-16
K092192 — WAYPOINT STEREOTACTIC SYSTEMFHC, Inc.·Product code HAW·2010-02-12
K092421 — ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTICGimmi GmbH·Product code HIH·2010-02-12
K092835 — COMFORTGEL NASAL MASKRespironics Inc., Sleep & Home Respiratory Group·Product code BZD·2010-02-12
K093004 — IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATINGMerit Medical Systems, Inc.·Product code DQO·2010-02-12
K093027 — STRAUMANN RC TEMPORARY ABUTMENTSStraumann USA·Product code DZE·2010-02-12
K093106 — ENDOSCOPE REPROCESSOR OER-PROOlympus Medical Systems Corporation·Product code FEB·2010-02-12
K093138 — MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003Shenzhen Dongdixin Technology Co., Ltd.·Product code IPF·2010-02-12
K093192 — FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICEAdvanced Vascular Dynamics·Product code JOM·2010-02-12
K093208 — SIMPLISEALDiscus Dental, LLC·Product code KIF·2010-02-12
K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENTDmg USA, Inc.·Product code EMA·2010-02-12
K093449 — MINI LAP RETRACTORSMini Lap Technologies, Inc.·Product code GCJ·2010-02-12
K093631 — B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644Siemens Healthcare Diagnostics·Product code CDD·2010-02-12
K093696 — SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803Central Medicare Sdn Bhd·Product code LZA·2010-02-12
K094019 — GLIDER PTA BALLOON CATHETERTrireme Medical, Inc.·Product code DQY·2010-02-12
K100061 — CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XXK2m, Inc.·Product code KWQ·2010-02-12
K100078 — MODIFIED STRAIGHT FIRE LASER FIBERBoston Scientific Corp·Product code GEX·2010-02-12
K100122 — MODIFICATION TO CAPSURE PS SYSTEMSpine Wave, Inc.·Product code MNH·2010-02-12
K100207 — NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8FTopcon Corp.·Product code HKI·2010-02-12
K090250 — ELECTRO-LIGHT THERAPYHill Laboratories Co.·Product code ILY·2010-02-11
K093379 — TCX-I-DV REMOTE CARE MANAGEMENT SYSTEMBl Healthcare, Inc.·Product code KDI·2010-02-09
K093637 — JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300Jms North America Corp.·Product code FIE·2010-02-09
K090264 — HEMOSIL D-DIMER HS 500, CONTROLSInstrumentation Laboratory CO·Product code DAP·2010-02-05
K091210 — ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANTBest Sanitizers, Inc.·Product code MED·2010-02-05
K091493 — ORTHO SELECT BONE PLATES AND SCREW SYSTEMOrtho Select Implant Technology Gesellschaft·Product code HRS·2010-02-05
K091757 — OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407Well-Life Healthcare Limited·Product code NUH·2010-02-05
K091769 — TRUST DAMLine One Laboratories, Inc.·Product code MSC·2010-02-05
K092142 — SPORT-ELEC BODY CONTROL SYSTEM BSSport-Elec·Product code NGX·2010-02-05
K093005 — FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264Taidoc Technology Corporation·Product code NBW·2010-02-05
K093007 — ENTELLUS MEDICAL BALLOON DEVICEEntellus Medical, Inc.·Product code LRC·2010-02-05
K093081 — POCKET BVMMicrobvm Systems , Ltd.·Product code BTM·2010-02-05
K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical Aps·Product code LKD·2010-02-05
K093476 — AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120Aga Medical Corp.·Product code DQY·2010-02-05
K093567 — ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEMAnova Implant Solutions, LLC·Product code JWH·2010-02-05
K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEIris International, Inc.·Product code LKM·2010-02-05
K082525 — CORIN METAFIX FEMORAL STEMCorin USA·Product code LZO·2010-02-04
K090609 — OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEMOk Biotech Co., Ltd.·Product code NBW·2010-02-04
K091077 — OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETERCordis Corp., A Johnson & Johnson Co.·Product code DTK·2010-02-04
K091363 — COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTERAg Industries·Product code CAH·2010-02-04
K091522 — IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISAImmco Diagnostics, Inc.·Product code MST·2010-02-04
K092527 — NEXUS INJECTION SITE, MODEL NIS-8Nexus Medical, LLC·Product code FPA·2010-02-04
K092531 — SPINE360 ANTERIOR CERVICAL PLATE SYSTEMSpine360·Product code KWQ·2010-02-04
K092574 — ESL SPINAL SYSTEMEbi, L.P.·Product code MAX·2010-02-04
K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190Roche Diagnostics Corp.·Product code NBC·2010-02-04
K092800 — ANTI-WRINKLE (AGING) LIGHT, MODEL AALLed Intellectual Properties, LLC·Product code ONE·2010-02-04
K092836 — OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141Depuy Mitek, A Johnson & Johnson Company·Product code MBI·2010-02-04
K092918 — PARI VIOSPari Respiratory Equipment, Inc.·Product code CAF·2010-02-04
K093059 — SELECT DEFENSE DENTAL PIT AND FISSURE SEALANTClassone Orthodontics, Inc.·Product code EBC·2010-02-04
K093062 — VERTOS MEDICAL MILD DEVICE KITX-Sten Corp.·Product code HRX·2010-02-04
K093142 — TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEMBoston Scientific Corp·Product code HCG·2010-02-04
K093444 — EXAPACSMedincom Technology Corp·Product code LLZ·2010-02-04
K093688 — CANON, MODEL URS-50RFVirtual Imaging, Inc.·Product code OWB·2010-02-04
K093846 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERSZimmer, Inc.·Product code LZO·2010-02-04
K093927 — 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETERC.R. Bard, Inc.·Product code LJS·2010-02-04
K100044 — FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODYBlackstone·Product code NKB·2010-02-04
K100070 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEMDepuy Spine, Inc.·Product code KWQ·2010-02-04
K100192 — STRONG DENTAL HANDPIECESSaeshin Precision Co., Ltd.·Product code EGS·2010-02-04
K082230 — VECTRA PLUS LASER SYSTEM AND ACCESSORIESXintec Corporation·Product code GEX·2010-02-03
K083764 — AMPHETAMINES IIRoche Diagnostics Corp.·Product code DKZ·2010-02-03
K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZESMedefil, Inc.·Product code NZW·2010-02-03
K092746 — MICRONJET 600Nanopass Technologies , Ltd.·Product code FMI·2010-02-03
K093496 — NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENTOon Corp. Resources·Product code LYY·2010-02-03
K093572 — R650 QDASM COLLIMATOROmega Medical Imaging, Inc.·Product code IZW·2010-02-03
K092774 — ATLAS INTERVERTEBRAL BODY CAGESpinal Edge, LLC·Product code MAX·2010-02-02
K092970 — GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.·Product code MHX·2010-02-02
K093474 — DEPUY FRACTURE AND FUSION PLATING SYSTEMDePuy Orthopaedics, Inc.·Product code HRS·2010-02-02
K100063 — HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODELEv3, Inc.·Product code MJN·2010-02-02
K100090 — IMPLANTABLE CLIPGenicon·Product code FZP·2010-02-02
K100146 — EVOLVE EPS ORTHOLOCWrightmedicaltechnologyinc·Product code HRS·2010-02-02
K082315 — EC50 MICRO+ SMOKERLYZERBedfont Scientific, Ltd.·Product code CCJ·2010-02-01
K090111 — FLEXPEN NEEDLENovo Nordisk, Inc.·Product code FMI·2010-02-01
K090755 — QUANTA LITE APS/PT IGG AND IGM ELISAInova Diagnostics, Inc.·Product code OPN·2010-02-01
K092821 — TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021Agency For Medical Innovations, Inc.·Product code GCJ·2010-02-01
K092897 — LAP LOOPMedsys, S.A.·Product code KNF·2010-02-01
K093112 — DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGEColoplast Manufacturing Us, LLC·Product code GAW·2010-02-01
K093284 — 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COILInvivo Corporation·Product code MOS·2010-02-01
K093310 — GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Micro Companies Alliance, Inc.·Product code MVR·2010-02-01
K093563 — IU22 ULTRASOUND SYSTEM AND TRANSDUCERSPhilips Ultrasound, Inc.·Product code IYN·2010-02-01
K093727 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLORZibo Bolin Gloves Co., Ltd.·Product code LYZ·2010-02-01
K090427 — URSA ANGIOGRAPHIC CATHETERCurative Medical Technology, Inc.·Product code DQO·2010-01-29
K092828 — STATNET, MODEL 3100Hydrodot, Inc.·Product code GXY·2010-01-29
K093416 — TRILOGY 200 VENTILATORRespironics, Inc.·Product code CBK·2010-01-29
K100014 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557Andon Health Co, Ltd.·Product code DXN·2010-01-29
K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROLR&D Systems, Inc.·Product code JPK·2010-01-29
K100117 — LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATORShenzhen Dongdixin Technology Co., Ltd.·Product code IPF·2010-01-29
K091278 — VALEO SPACER SYSTEMAmedica Corp.·Product code MAX·2010-01-28
K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGEMedefil, Inc.·Product code NGT·2010-01-28
K091794 — CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202Steve Islava·Product code CAF·2010-01-28
K092176 — TAKE 1 ADVANCED RIGID TRAYKerr Corporation·Product code ELW·2010-01-28
K092508 — FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,Smith & Nephew, Inc.·Product code GAT·2010-01-28
K092589 — THERMOTEX PLATINUM SYSTEMEas Consulting Group, LLC·Product code ILY·2010-01-28
K093021 — ATLANTIS SLIT LAMPUs Opthalmic, LLC·Product code HJO·2010-01-28
K093143 — MISSION BREATH ALCOHOL DETECTORACON Laboratories, Inc.·Product code DJZ·2010-01-28

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