FDA 510(k) clearances — page 450

176,542 clearances on record, most recent first.

Clearances — page 450

44,901–45,000 of 176,542

K120559 — AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEMAesculap, Inc.·Product code JXG·2012-05-24
K120601 — GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OGeistlich Pharma AG·Product code NPM·2012-05-24
K120633 — MAYFIELD SKULL CLAMPIntegra LifeSciences Corporation·Product code HBL·2012-05-24
K120767 — ES BONDSpident Co., Ltd.·Product code KLE·2012-05-24
K120811 — LEKSELL GAMMA KNIFE PERFEXIONElekta Instrument AB·Product code IWB·2012-05-24
K120840 — LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEML&K BIOMED Co., Ltd.·Product code ODP·2012-05-24
K120895 — REMOTE PRESENCE SYSTEMIntouch Health, Inc.·Product code DRG·2012-05-24
K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical Company·Product code DBF·2012-05-24
K121236 — PAX-DUO3D PLUS, PCT-5000VATECH Co., Ltd.·Product code OAS·2012-05-24
K121239 — MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVEOptoacoustics, Ltd.·Product code LNH·2012-05-24
K110632 — LUCENT OR LUCENT MAGNUMSpinal Elements, Inc.·Product code MAX·2012-05-23
K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPOlsen Medical·Product code GEI·2012-05-23
K111476 — CONTOUR TECHNOLOGY MUSCLE STIMULATORContour Technology·Product code NGX·2012-05-23
K111575 — HEMASORB ABSORBABLE BONE HEMOSTAT MATRIXOrthocon, Inc.·Product code MTJ·2012-05-23
K112800 — SUNTOUCH TOPICAL HEMOSTATIC DRESSINGHuizhou Foryou Medical Devices Co., Ltd.·Product code QSY·2012-05-23
K113287 — SOMATOM PERSPECTIVESiemens Medical Solutions USA, Inc.·Product code JAK·2012-05-23
K113440 — HIGH FIVECentral Medicare Sdn Bhd·Product code LZA·2012-05-23
K120179 — REACH SURGICAL STAPLERSReach Surgical, Inc.·Product code GDW·2012-05-23
K120191 — PUSH-ON NEEDLE 30GX8MMScandinavian Health Limited·Product code FMI·2012-05-23
K120284 — DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEXColoplast A/S·Product code NEW·2012-05-23
K120487 — VANTAGE TITAN 3TToshibamedical Systems Corporation·Product code LNH·2012-05-23
K120515 — TEMPUS CERVICAL PLATE SYSTEMNeurostructures, LLC·Product code KWQ·2012-05-23
K120556 — VILET VILET QUICKRiverpoint Medical·Product code GAM·2012-05-23
K120579 — SOMATOM DEFINITION EDGESiemens Medical Systems, Inc.·Product code JAK·2012-05-23
K120622 — PALOMAR VECTUS LASERPalomar Medical Technologies, Inc.·Product code GEX·2012-05-23
K120879 — LEXUS CERVICAL FIXATION SYSTEML&K BIOMED Co., Ltd.·Product code MNI·2012-05-23
K120934 — PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESSCardinal Health, Inc.·Product code KGO·2012-05-23
K120976 — MANUKA IGLinks Medical Products, Inc.·Product code FRO·2012-05-23
K121109 — AERODR X70Konica Minolta Medical & Graphic, Inc.·Product code KPR·2012-05-23
K121227 — MANUKA FILLLinks Medical Products, Inc.·Product code FRO·2012-05-23
K121384 — MYLABSOGNOEsaote, S.p.A.·Product code IYN·2012-05-23
K111862 — VIEWRAY SYSTEMViewray, Incorporated·Product code IYE·2012-05-22
K112527 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717Meridian Medical Systems, LLC·Product code MQB·2012-05-22
K112881 — NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)Nexstim OY·Product code GWF·2012-05-22
K113103 — SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICERex Medical·Product code PNO·2012-05-22
K120013 — TEMPSPAN CLEAR MATRIXPentron Clinical·Product code ELW·2012-05-22
K120042 — TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code LFR·2012-05-22
K120443 — NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICEBaxter Healthcare Corporation - Renal Division·Product code FPA·2012-05-22
K120533 — BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRESBridgepoint Medical·Product code PDU·2012-05-22
K120586 — CELL SAVER ELITEHaemonetics Corp.·Product code CAC·2012-05-22
K121263 — TAPER SET HIP SYSTEM RDP STEMConsensus Orthopedics, Inc.·Product code LPH·2012-05-22
K121265 — AMPHIRION PLUS PTA CATHETERMedtronic, Inc.·Product code LIT·2012-05-22
K120104 — VISIONSEARCH 1Visionsearch Pty, Ltd.·Product code GWE·2012-05-21
K120130 — FALLER TROCARMedigroup, Inc.·Product code FJS·2012-05-21
K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbH·Product code ELM·2012-05-21
K120419 — DYNA LOCKING ANKLE NAILU&I Corp.·Product code HSB·2012-05-21
K120495 — IMPULSE AND EXPO ANGIOGRAPHIC CATHETERBoston Scientific Corp·Product code DQO·2012-05-21
K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVENovocol, Inc.·Product code DYH·2012-05-21
K111450 — MIROCAM CAPSULE ENDOSCOPE SYSTEMIntromedic Co., Ltd.·Product code NEZ·2012-05-18
K112457 — LEFORTE SYSTEM BONE PLATE & SCREWArkin Consulting Group·Product code JEY·2012-05-18
K112698 — CONCENTRIC BALLOON GOOGLEUnited States Endoscopy Group, Inc.·Product code ODC·2012-05-18
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.·Product code KWA·2012-05-18
K113565 — MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARINEdwards Lifesciences, LLC·Product code FOZ·2012-05-18
K113576 — DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEMEtview , Ltd.·Product code CBI·2012-05-18
K113622 — ORION II CT CVCHealth Line International Corporation (Hlic)·Product code FOZ·2012-05-18
K120091 — R&D INNOVATION PEDICLE SCREW SYSTEMR&D Innovation, LLC·Product code NKB·2012-05-18
K120099 — RANGE SPINAL SYSTEM (MESA AND DENALI)K2m, Inc.·Product code MNI·2012-05-18
K120299 — SRS ENDOSCOPIC STAPLING SYSTEMMedigus , Ltd.·Product code ODE·2012-05-18
K120605 — PERMACOL SURGICAL IMPLANTCovidien, LLC·Product code FTM·2012-05-18
K120698 — GENESIS II PS NON-MODULAR FEMORAL COMPONENTSmith & Nephew, Inc.·Product code JWH·2012-05-18
K120911 — XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)Cepheid·Product code OQW·2012-05-18
K120928 — SYNTHES MATRIX SYSTEMSynthes Spine·Product code NKB·2012-05-18
K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad Laboratories·Product code DIF·2012-05-18
K121207 — EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.·Product code LFR·2012-05-18
K121237 — BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LECliniqa Corporation·Product code JJX·2012-05-18
K112322 — RESTORELLE POLYPROPYLENE Y MESHColoplast A/S·Product code OTO·2012-05-17
K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code JJE·2012-05-17
K113281 — MRI SYTEMSShenzhen Anke High-Tech Co., Ltd.·Product code LNH·2012-05-17
K113510 — EVOLUTION COLONIC STENT SYSTEMCook Ireland, Ltd.·Product code MQR·2012-05-17
K120059 — LIQUID BANDAGEChesson Laboratory Associates, Inc.·Product code KMF·2012-05-17
K120440 — PRESTO BREAST BIOPSY DEVICESontina Medical, LLC·Product code KNW·2012-05-17
K120489 — TISSUE OF ORIGIN TEST KIT FFPEPathwork Diagnostics, Inc.·Product code OIW·2012-05-17
K120493 — MINI CANNULATED HEADED AND HEADLESS SCREW SETInstratek, Inc.·Product code HWC·2012-05-17
K120516 — LONG LIFE PADTMOmron Healthcare, Inc.·Product code GXY·2012-05-17
K120729 — HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23Ethicon Endo-Surgery, LLC·Product code LFL·2012-05-17
K120894 — HAYMAXHaymax Limited·Product code NUP·2012-05-17
K121009 — HEARTCHECK ECG PEN WITH GEMS HOMECardiocomm Solutions, Inc.·Product code DPS·2012-05-17
K121138 — ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solution·Product code IYN·2012-05-17
K121174 — XPRESS MULTI-SINUS DILATION TOOLEntellus Medical, Inc.·Product code LRC·2012-05-17
K121314 — ARCHITECT B12Abbott Laboratories·Product code CDD·2012-05-17
K121339 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSChemtron Biotech, Inc.·Product code DKZ·2012-05-17
K103658 — FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERTeleflex, Inc.·Product code CAZ·2012-05-16
K112127 — PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEMSmith & Nephew, Inc.·Product code OMP·2012-05-16
K112494 — VARAYA AR , VARAYA SPORTVaraya Photoceuticals, LLC·Product code ILY·2012-05-16
K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEMMedicalgorithmics S.A.·Product code DSI·2012-05-16
K113050 — CLEARPATH LOWER GIEasyglide , Ltd.·Product code FDF·2012-05-16
K113166 — CLEARPATH UPPER GIEasyglide , Ltd.·Product code FDS·2012-05-16
K120035 — APEX MEDICAL ICH CPAP SERIES (9S-007XXX)Apex Medical Corp.·Product code BZD·2012-05-16
K120173 — PATIENT MONITOREdan Instruments, Inc.·Product code MHX·2012-05-16
K120216 — GENOSYL MV-1000Geno, LLC·Product code MRN·2012-05-16
K120287 — TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANTChurch & Dwight Co., Inc.·Product code HIS·2012-05-16
K121124 — ARTHREX MIXING AND DELIVERY SYSTEMArthrex, Inc.·Product code FMF·2012-05-16
K121149 — VANGUARD SSK 360 REVISION KNEE SYSTEMBiomet Manufacturing Corp·Product code JWH·2012-05-16
K121186 — RADIAL JAW 4 PULMONARY BIOPSY FORCEPSBoston Scientific Corp·Product code BWH·2012-05-16
K111940 — S 100 PEDICLE SCREW SYSTEMRenovis Surgical Technologies, LLC·Product code MNH·2012-05-15
K120267 — FILMARRAY RP PANELIdaho Technology, Inc.·Product code OCC·2012-05-15
K120681 — ADVIA CHEMISTRY GLUH_3 REAGENTSSiemens Healthcare Diagnostics, Inc.·Product code CFR·2012-05-15
K120707 — SWITCH-IT CATHETERVascular Solutions, Inc.·Product code DQY·2012-05-15
K121141 — TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEMTensys Medical Systems, Inc.·Product code DXN·2012-05-15
K121223 — QLAB WITH FHN AND VPQ PLUG-INPhilips Ultrasound, Inc.·Product code LLZ·2012-05-15

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