FDA 510(k) clearances — page 374

176,542 clearances on record, most recent first.

Clearances — page 374

37,301–37,400 of 176,542

K142187 — LINK MP RECONSTRUCTION PROSTHESISWaldemar Link GmbH & Co. KG·Product code LZO·2014-11-06
K142640 — Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential CirculatorBio Compression Systems, Inc.·Product code JOW·2014-11-06
K142684 — FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP·Product code DYB·2014-11-06
K132230 — ICE ZIRKON TRANSLUZENTZirkonzahn Srl·Product code EIH·2014-11-05
K133507 — GUIDOSSNibec Co., Ltd.·Product code NPL·2014-11-05
K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code KWQ·2014-11-05
K141649 — SPEX SUPPORT CATHETERReflow Medical·Product code DQY·2014-11-05
K141909 — COLLAGEN DENTAL MEMBRANE - CONFORMABLE PPCollagen Matrix, Inc.·Product code NPL·2014-11-05
K142020 — LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400Biomonde·Product code NQK·2014-11-05
K142470 — E-Shield Multi-paried Subdermal Needle ElectrodesNeuroinvent, Inc.·Product code GXZ·2014-11-05
K142950 — Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc.·Product code OCY·2014-11-05
K140193 — DUREX EMBRACE PERSONAL LUBRICANTReckitt Benckiser, LLC·Product code NUC·2014-11-04
K140738 — PASS LP SPINAL SYSTEMMedicrea International·Product code MNI·2014-11-04
K141338 — LIAT STREP A ASSAYIquum, Inc.·Product code PGX·2014-11-04
K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEMRenovis Surgical Technologies, Inc.·Product code LPH·2014-11-04
K142489 — Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.·Product code DSA·2014-11-04
K141238 — STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATORSterilucent, Inc.·Product code FRC·2014-11-03
K140008 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEMTerumo Cardiovascular Systems Corporation·Product code GEI·2014-10-31
K140293 — TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEMAdin Dental Implants Systems , Ltd.·Product code DZE·2014-10-31
K140464 — STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZERSterilucent, Inc.·Product code MLR·2014-10-31
K141126 — UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLEUnisis Corp.·Product code BSP·2014-10-31
K141207 — NOVABONE BIOACTIVE STRIPNovabone Products, LLC·Product code MQV·2014-10-31
K141312 — STERILUCENT PROCESS CHALLENGE DEVICESterilucent, Inc.·Product code FRC·2014-10-31
K141570 — IMPLANT STUDIO3Shape Medical A/S·Product code LLZ·2014-10-31
K141660 — NAWALUTION SKIN AND WOUND CLEANSERNawa Heilmittel GmbH·Product code FRO·2014-10-31
K141700 — PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGenoray Co., Ltd.·Product code MUH·2014-10-31
K141745 — IQQA-BODYIMAGING SOFTWAREEdda Technology·Product code LLZ·2014-10-31
K141758 — T:SLIM INSULIN DELIVERY SYSTEMTandem Diabetes Care, Inc.·Product code LZG·2014-10-31
K141881 — RAPIDRESULTSRamsoft, Inc.·Product code LLZ·2014-10-31
K141941 — SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES DStryker Corporate·Product code OLO·2014-10-31
K142088 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIESGrandway Technology (Shenzhen) Limited·Product code DXN·2014-10-31
K142286 — NS3000 Holmium Laser SystemNew Star Lasers, Inc.·Product code GEX·2014-10-31
K142484 — Sternal Closure SystemJace Medical, LLC·Product code HRS·2014-10-31
K142517 — SoftVueDelphinus Medical Technologies, Inc.·Product code IYO·2014-10-31
K142575 — Bard RiteCath Intermittent Urinary CatheterC.R. Bard, Inc.·Product code EZD·2014-10-31
K132853 — NOVAPACSNovarad Corp.·Product code LLZ·2014-10-30
K133810 — VC150 VITAL SIGNS MONITORInnokas Yhtyma·Product code MWI·2014-10-30
K140051 — KJ EXTERNAL IMPLANT SYSTEMKj Meditech Co., Ltd.·Product code DZE·2014-10-30
K140052 — J2I IMPLANT SYSTEMKj Meditech Co., Ltd.·Product code DZE·2014-10-30
K140493 — ELIA SCL-70S IMMUNOASSAYPhadia GmbH·Product code LJM·2014-10-30
K140590 — ASTROGLIDE SENSUAL STRAWBERRYBiofilm, Inc.·Product code NUC·2014-10-30
K142078 — VELASII THERAPY LASER SYSTEMAspen Laser Systems, LLC·Product code ILY·2014-10-30
K142138 — ISO-GARD MASKTeleflexmedical, Inc.·Product code CBN·2014-10-30
K142372 — Pico Way Laser SystemCandela Corpation·Product code GEX·2014-10-30
K142414 — Miltex N-Tralig Intraligamentary SyringeIntegra LifeSciences Corporation·Product code EJI·2014-10-30
K142443 — Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.·Product code IYO·2014-10-30
K142851 — CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact LensUnilens Corp., USA·Product code LPL·2014-10-30
K142869 — Premium Surgiclip IIICovidien·Product code FZP·2014-10-30
K142878 — IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.·Product code JJX·2014-10-30
K141539 — KUBTEC X250Kub Technologies, Inc.·Product code IZL·2014-10-29
K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BONAdvanced Orthopaedic Solutions, Inc.·Product code KTT·2014-10-29
K142050 — NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEMNu Vasive, Incorporated·Product code ODP·2014-10-29
K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEMZimmer Spine, Inc.·Product code OWI·2014-10-29
K142090 — REBOSSISOrthorebirth Co., Ltd.·Product code MQV·2014-10-29
K142150 — AIS MODULIFT VBR SYSTEMAesculap Implant System, Inc.·Product code MQP·2014-10-29
K142199 — Ascendra Balloon Aortic Valvaloplasty CatheterEdwards Lifesciences·Product code OZT·2014-10-29
K142245 — EpiAccess SystemEpiep, Inc.·Product code DYB·2014-10-29
K142441 — cryoICE croablation probeAtriCure, Inc.·Product code GEH·2014-10-29
K142811 — IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)Siemens Healthcare Diagnostics, Inc.·Product code JJX·2014-10-29
K142864 — ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)Siemens Healthcare Diagnostics, Inc.·Product code JJX·2014-10-29
K142984 — Leo MinorSunnex, Inc.·Product code FSY·2014-10-29
K132771 — KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTSQingdao Kingston Medical Devices, Ltd.·Product code GEI·2014-10-28
K140020 — HYPERQ ACS-100 SYSTEMBsp-Biiological Signal Processing, Ltd.·Product code DPS·2014-10-28
K140383 — ALLOX2 TISSUE EXPANDERSSpecialty Surgical Products, Inc.·Product code LCJ·2014-10-28
K141221 — LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PRLares Research, Inc.·Product code EFB·2014-10-28
K141459 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0Toshibamedical Systems Corporation·Product code IYN·2014-10-28
K141686 — EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODYSmith Medical Asd, Inc.·Product code DWJ·2014-10-28
K141713 — SMARTGRAFT 200 SYSTEMIngeneron, Inc.·Product code MUU·2014-10-28
K142063 — #8C RENEGADE DENTAL HANDPIECEHandpiece Club, LLC·Product code EFB·2014-10-28
K142082 — ZIMMER 3.1MM DENTAL IMPLANT; 2.9MM ANGLED ABUTMENT; STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENTZimmer Dental, Inc.·Product code DZE·2014-10-28
K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXNcontact Surgical, Inc.·Product code OCL·2014-10-28
K142170 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GPBecton, Dickinson and Company·Product code LON·2014-10-28
K142563 — Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.·Product code EZD·2014-10-28
K142654 — Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC·Product code LIT·2014-10-28
K142733 — E-CUBE 5Alpinion Medical Systems Co., Ltd.·Product code IYN·2014-10-28
K142884 — E-CUBE 12Alpinion Medical Systems Co., Ltd.·Product code IYN·2014-10-28
K142900 — Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating MeshSofradim Production·Product code FTL·2014-10-28
K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POPhadia US, Inc.·Product code MOB·2014-10-27
K140940 — PROCESS INDICATOR TAPE FOR STEAM STERILIZATIONCanadian Technical Tape, Ltd.·Product code JOJ·2014-10-27
K141331 — BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)Biomet, Inc.·Product code JDI·2014-10-27
K141407 — VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIALBiomet, Inc.·Product code MBH·2014-10-27
K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMDefibtech, LLC·Product code DRM·2014-10-27
K141850 — FLOSPINE PEDICLE SCREW SYSTEMFlospine·Product code NKB·2014-10-27
K141953 — ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLTitan Spine, LLC·Product code MAX·2014-10-27
K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMISRti Surgical, Inc.·Product code FTM·2014-10-27
K142114 — Xia® Growth Rod Conversion SetStryker Corporation·Product code PGM·2014-10-27
K142425 — UroflowmeterBe Technologies, Inc.·Product code EXY·2014-10-27
K142847 — CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.·Product code NKB·2014-10-27
K133069 — CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIESCodent Technical Industry Co., Ltd.·Product code EFB·2014-10-24
K133225 — E-FIT EF-1280 EMS MACHINEFit-Pro Kft , Ltd.·Product code NGX·2014-10-24
K140022 — NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCTCork Medical Products, LLC·Product code OMP·2014-10-24
K140647 — XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)Luminex Molecular Diagnostics, Inc.·Product code PCH·2014-10-24
K140684 — CLINPRO PROPHY POWDER3M Deutschland GmbH·Product code PIP·2014-10-24
K140927 — UNIVERSAL NAVIGATION INSTRUMENTSMedos International SARL·Product code OLO·2014-10-24
K141175 — RENOVOCATH RC120Renovorx, Inc.·Product code MJN·2014-10-24
K141564 — OPTON PROZimmer Medizinsystems GmbH·Product code ILY·2014-10-24
K141714 — PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEMWrightmedicaltechnologyinc·Product code HTY·2014-10-24
K141731 — NEPHROS DSU-H, NEPHROS SSU-HNephros, Inc.·Product code NHV·2014-10-24
K141759 — OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERSOak Ridge Products, LLC·Product code MMK·2014-10-24
K142079 — STALIF CTI, STALIF CCentinel Spine, Inc.·Product code OVE·2014-10-24

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