FDA 510(k) clearances — page 378

176,542 clearances on record, most recent first.

Clearances — page 378

37,701–37,800 of 176,542

K140928 — ABPM7100I.E.M. GmbH·Product code DXN·2014-09-15
K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KITProcter & Gamble Co.·Product code JEQ·2014-09-15
K141122 — HARMONIC SCALLOP BLADE, GENERATOR G11Ethicon Endo-Surgery, LLC·Product code GEI·2014-09-15
K141137 — STEREOS WORKSTATIONEos Imaging·Product code LLZ·2014-09-15
K141321 — GLUCOSTABILIZER INSULIN DOSING CALCULATORMedical Decision Network·Product code NDC·2014-09-15
K142295 — Sirius Femoral Stem, Size 30ABiomet, Inc.·Product code JDI·2014-09-15
K142306 — Flower Upper Extremity Plating SetFlower Orthopedics Corporation·Product code HRS·2014-09-15
K133983 — INTRA. OX HANDHELD TISSUE OXIMETERVioptix, Inc.·Product code MUD·2014-09-12
K140050 — NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUEHartalega Sdn Bhd·Product code LZA·2014-09-12
K140367 — ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIXHarbor Medtech, Inc.·Product code KGN·2014-09-12
K140608 — MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIREMerit Medical Systems, Inc.·Product code DQX·2014-09-12
K141025 — ARTIMES BALLOON DILATATION CATHETERBrosmed Medical·Product code LOX·2014-09-12
K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIVArgentum Medical, LLC·Product code OMP·2014-09-12
K141235 — PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMSMicroport Orthopedics, Inc.·Product code LZO·2014-09-12
K141384 — WHISPERJECT AUTOINJECTORScandinavian Health Limited·Product code KZH·2014-09-12
K141419 — ZVPLASTYZavation, LLC·Product code NDN·2014-09-12
K141439 — ORTHODONTIC ACRYLIC (NOT FINALIZED)Bisco, Inc.·Product code EBI·2014-09-12
K141602 — DX-D IMAGING PACKAGEAgfa Healthcare N.V.·Product code MQB·2014-09-12
K141949 — CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUMAap Implantate AG·Product code HWC·2014-09-12
K141971 — BIOGRAPH TRUE PET/CT FAMILY SOFTWARESiemens Medical Solutions USA, Inc.·Product code KPS·2014-09-12
K142008 — MYLABSEVEN, MYLABALPHAEsaote, S.p.A.·Product code IYN·2014-09-12
K142077 — MYLABGAMMAEsaote, S.p.A.·Product code IYN·2014-09-12
K142134 — C-WIRE DOUBLE ENDED ORTHOPEDIC WIRESConmed Corporation, Largo·Product code HTY·2014-09-12
K142223 — Pilot Pro Diode LaserCAO Group, Inc.·Product code GEX·2014-09-12
K142225 — Pilot Elite Diode LaserCAO Group, Inc.·Product code GEX·2014-09-12
K142226 — Pilot Ultra Diode LaserCAO Group, Inc.·Product code GEX·2014-09-12
K142241 — LARIAT sulture Delivery DeviceSentreheart, Inc.·Product code GAT·2014-09-12
K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTONxstage Medical, Inc.·Product code FIE·2014-09-11
K140429 — CRANE ACRYLIC HERBST APPLIANCECrane Dental Laboratory, Inc.·Product code LRK·2014-09-11
K140841 — TABLO CARTRIDGEHome Dialysis Plus·Product code FJK·2014-09-11
K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDERanfac, Corp.·Product code KNW·2014-09-11
K141079 — OPTIMEDICA CATALYS PRECISION LASER SYSTEMOptimedica Corporation·Product code OOE·2014-09-11
K141425 — ELITE + LASER SYSTEMCynosure, Inc.·Product code GEX·2014-09-11
K141601 — IASSIST KNEE SYSTEMZimmer Cas·Product code OLO·2014-09-11
K130742 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Dahoon Plastic Co., Ltd.·Product code LYZ·2014-09-10
K131983 — ITRAC CERVICAL TRACTION SYSTEMPivotal Health Solutions·Product code ITH·2014-09-10
K134040 — BTL-9000; BTL-9000 RADIOFREQUENCY MODULEBtl Industries, Ltd.·Product code OLI·2014-09-10
K140167 — RENAISSANCE X SYSTEMMazor Robotics , Ltd.·Product code OLO·2014-09-10
K140195 — SURGICAL DRAPEGriffith-Lucas, LLC·Product code KKX·2014-09-10
K140390 — TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESISBiomet Manufacturing Corp·Product code MBF·2014-09-10
K140488 — CONTACT LENS CASEMaca Plastics, Inc.·Product code LRX·2014-09-10
K140780 — KEGEL SMART, KEGELSMART PEARLRegulatory Insight, Inc.·Product code HIR·2014-09-10
K140866 — TABLO CONSOLEHome Dialysis Plus·Product code KDI·2014-09-10
K141464 — NOVAGUARD S A SAFETY SYSTEMWest Pharmaceutical Services·Product code MEG·2014-09-10
K141565 — GLOBE-TROTTER GT5400Draeger Medical Systems, Inc.·Product code FPL·2014-09-10
K141835 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODSSpineart·Product code MNI·2014-09-10
K141937 — TRIDENT FUSION IMPLANTVilex IN Tennessee, Inc.·Product code HWC·2014-09-10
K142213 — VIA SPINOUS PROCESS FIXATION SYSTEMSpineology, Inc.·Product code PEK·2014-09-10
K142230 — Apollo Suture Anchor System and Titan ScrewsValeris Medical·Product code MBI·2014-09-10
K142259 — Direxion Torqueable MicrocatheterBoston Scientific Corp·Product code KRA·2014-09-10
K142423 — EyeSuite ImagingHaag-Streit AG·Product code NFJ·2014-09-10
K131340 — POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVESMade Plastic Co., Ltd.·Product code LYZ·2014-09-09
K133963 — SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC·Product code MPN·2014-09-09
K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATORFujifilm Medical System U.S.A., Inc.·Product code FCX·2014-09-09
K141068 — ZEISS CATARACT SUITE MARKERLESSCarl Zeiss Meditec, AG·Product code HJO·2014-09-09
K141156 — SPACELABS HEALTHCARE TELEMETRY RECEIVERSpacelabs Healthcare·Product code MHX·2014-09-09
K141244 — NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)North American Science Assoc., Inc.·Product code FRC·2014-09-09
K141706 — ECARE COORDINATOR (ECC)Visicu, Inc.·Product code DRG·2014-09-09
K142182 — FRIMAP ADAPTER CONNECTOR (MAC)Topera, Inc.·Product code MTD·2014-09-09
K142395 — SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.·Product code IYO·2014-09-09
K133584 — IN TOUCH BLOOD GLUCOSE MONITORING SYSTEMEoshealth, Inc.·Product code CGA·2014-09-08
K141337 — ARENA-CSpinefrontier, Inc.·Product code ODP·2014-09-08
K141541 — XIDF-AWS801, ANGIO WORKSTATION, V5.31Toshibamedical Systems Corporation·Product code JAA·2014-09-08
K141551 — PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)Stryker Corporate·Product code PGW·2014-09-08
K141873 — RANGE/MESA/DENALI SPINAL SYSTEMK2m, Inc.·Product code NKB·2014-09-08
K141924 — HD BLOOD PRESSURE MONITORBiocare Asia Corporation , Ltd.·Product code DXN·2014-09-08
DEN130031 — NEPHROCHECK TEST SYSTEMAstute Medical, Inc.·Product code PIG·2014-09-05
K131968 — LONGFIAN OXYGEN CONCENTRATORLongfian Scitech Co., Ltd.·Product code CAW·2014-09-05
K132245 — AJAX DENTAL UNITPro Dental Services, LLC·Product code EIA·2014-09-05
K133324 — SURESUBTRACTION LUNGToshiba Medical Systems Corporation, Japan·Product code JAK·2014-09-05
K133739 — TRUSCULPTCutera, Inc.·Product code PBX·2014-09-05
K133895 — DEKA SMARTXIDE LASER SYSTEMEl.En S.P.A.·Product code GEX·2014-09-05
K134025 — AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CTToshibamedical Systems Corporation·Product code JAK·2014-09-05
K140013 — SOPIX INSIDE, SOPIX2 INSIDESopro - Acteon Group·Product code MUH·2014-09-05
K140280 — FORTICORENanovis, LLC·Product code ODP·2014-09-05
K140528 — TRUE BEAM, TRUE BEAM STX, EDGEVarian Medical Systems, Inc.·Product code IYE·2014-09-05
K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc.·Product code GKZ·2014-09-05
K141248 — SMART SEGMENTATION KNOWLEDGE BASED CONTOURINGVarian Medical Systems, Inc.·Product code MUJ·2014-09-05
K141343 — AXXENT CERVICAL APPLICATORIcad, Inc.·Product code JAD·2014-09-05
K141552 — ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMSCare Fusion·Product code KNW·2014-09-05
K141562 — MSN-006GC America, Inc.·Product code EBG·2014-09-05
K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·Product code IYE·2014-09-05
K141574 — ARTIS ZEE/ZEEGO SW VC21Siemens Medical Solutions USA, Inc.·Product code OWB·2014-09-05
K141824 — MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIPMedtronic Sofamor Danek, Inc.·Product code MQV·2014-09-05
K142035 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMArkray Factory, Inc.·Product code NBW·2014-09-05
K142105 — ELI 380 ELECTROCARDIOGRAPHMortara Instrument, Inc.·Product code DPS·2014-09-05
K142127 — ELECSYS ESTRADIOL III CALCHECK 5Roche Diagnostics·Product code JJX·2014-09-05
K142157 — PALACOS R+G PROHeraeus Medical GmbH·Product code LOD·2014-09-05
K133797 — QMASTER-H/REVOTelesystems Co., Ltd.·Product code OAS·2014-09-04
K133889 — PREMIUMCousin Biotech Sas·Product code FTL·2014-09-04
K134003 — RHINIX NASAL FILTERRhinix Aps·Product code NUP·2014-09-04
K140710 — BIOMET GRAFT DELIVERY SYRINGESBiomet Spine (Aka Ebi, LLC)·Product code FMF·2014-09-04
K140947 — COMPAT ENTERAL DELIVERY PUMP SETSNestle Healthcare Nutrition, Inc.·Product code PIF·2014-09-04
K140964 — CALCULASE IIKARL STORZ Endoscopy-America, Inc.·Product code GEX·2014-09-04
K141272 — FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATORMinimmally Invasive Devices·Product code GCJ·2014-09-04
K141673 — IVAS 8 GAUGE BONE BIOPSY KITStryker Corporation·Product code KNW·2014-09-04
K141719 — BIOGEL PL MICRO SURGICAL GLOVEMolnlycke Health Care Us, LLC·Product code KGO·2014-09-04
K141831 — HYDRAVIEW GUIDEWIREBrivant Limited·Product code DQX·2014-09-04
K141950 — HFD100 ROCKER ARM ACCESSORYImris, Inc.·Product code HBL·2014-09-04
K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TESTAlere Scarborough, Inc.·Product code MYI·2014-09-03

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