FDA 510(k) clearances — page 449

176,542 clearances on record, most recent first.

Clearances — page 449

44,801–44,900 of 176,542

K112191 — HEALEX BIOSPONGE WOUND DRESSINGBionova Medical, Inc.·Product code KGN·2012-06-05
K113388 — CITIEFFE-TITANIUM CANNULATED SCREWCitieffe·Product code HWC·2012-06-05
K113703 — BAUSCH + LOMB NESOFILCON A CONTACT LENSBausch & Lomb, Incorporated·Product code LPL·2012-06-05
K113793 — HOMOCYSTEINE TESTRoche·Product code LPS·2012-06-05
K120054 — ULTIMA NEOPain Management Technologies·Product code GZJ·2012-06-05
K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEMCybersonics, Inc.·Product code FFK·2012-06-05
K120691 — BRAIN PORTNico Corporation·Product code GZT·2012-06-05
K120759 — CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONI-Sens, Inc.·Product code CGA·2012-06-05
K121387 — CENTRICITY PACS-IWGe Healthcare Integrated IT Solutions·Product code LLZ·2012-06-05
K121515 — ISOLAZ 2 INTENSE PULSED LIGHT SYSTEMSolta Medical, Inc.·Product code ONF·2012-06-05
K112766 — SNORKELFellmar Company·Product code LQZ·2012-06-04
K120370 — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERSZimmer, Inc.·Product code OQG·2012-06-04
K120435 — BROWNE ALDAHOL GLUTARALDEHYDE INDICATORSTERIS Corporation·Product code JOJ·2012-06-04
K120471 — MACH BRACKETS BRIGHT BRACKETSWorld Bio Tech Co., Ltd.·Product code NJM·2012-06-04
K120676 — S-250 PROTON BEAM RADIATION THERAPY SYSTEMMevion Medical Systems·Product code LHN·2012-06-04
K120689 — SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMSynthes (USA) Products, LLC·Product code HRS·2012-06-04
K120775 — LIGHT FOR WRINKLESLed Intellectual Properties, LLC·Product code OHS·2012-06-04
K121008 — TRILLIANT SURGICAL K-WIRESTrilliant Surgical, Ltd.·Product code HTY·2012-06-04
K121035 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530USFujifilm Medical System U.S.A., Inc.·Product code EOQ·2012-06-04
K121413 — CROSSFIX II MEMISCAL REPAIR DEVICECayenne Medical, Inc.·Product code GAT·2012-06-04
K113597 — MINI-LAP BIPOLAR ELECTROCAUTERY DEVICESMinilap Technologies·Product code GEI·2012-06-03
K120661 — THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREVidacare Corporation·Product code FMI·2012-06-03
K111798 — STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...Sterngold Dental, LLC·Product code DZE·2012-06-01
K112580 — COLLAGEN WOUND DRESSINGDalim Tissen Co., Ltd.·Product code KGN·2012-06-01
K112900 — SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSLima Corporate S.P.A.·Product code HSD·2012-06-01
K112937 — MRSA/SA ELITE MGBElitech·Product code NQX·2012-06-01
K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code JMO·2012-06-01
K113846 — BORRELIA BURGDORFERI IGM BLOT TESTGold Standard Diagnostics·Product code LSR·2012-06-01
K120346 — CLEANER ROTATIONAL THROMBECTOMY SYSTEMRex Medical·Product code MCW·2012-06-01
K120542 — CARDINAL HEALTH DURABLUE STERILIZATION WRAPCardinal Health-Medical Products and Services·Product code FRG·2012-06-01
K120638 — VANTAGE TITANToshibamedical Systems Corporation·Product code LNH·2012-06-01
K120672 — KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORAndon Health Co, Ltd.·Product code DXN·2012-06-01
K120679 — SYNAPSE 3D NODULE ANALYSISFujifilm Medical Systems U.S.A, Inc.·Product code LLZ·2012-06-01
K120763 — LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSLin-Zhi International, Inc.·Product code DJG·2012-06-01
K120779 — STRUCTUR 3Voco GmbH·Product code EBG·2012-06-01
K121073 — POWERGLIDE MIDLINE CATHETERC.R. Bard, Inc.·Product code FOZ·2012-06-01
K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPEThd Spa·Product code FER·2012-06-01
K121345 — SR SUITE 1.0Halifax Biomedical, Inc.·Product code KPR·2012-06-01
K121350 — VIRTUSO SYSTEM FOR IHC (DO-7)Ventana Medical Systems, Inc.·Product code NOT·2012-06-01
K110734 — NCI SPATULAFischer Surgical, Inc.·Product code OTZ·2012-05-31
K111382 — CELVERCellulose Concepts, LLC·Product code FRO·2012-05-31
K120033 — ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITKci USA, Inc.·Product code OMP·2012-05-31
K120441 — GETINGE 700HC-E SERIES STEAM STERILIZERGetinge Sourcing, LLC·Product code FLE·2012-05-31
K120620 — CLEAN AND BOOSTApex Dental Materials, Inc.·Product code KLE·2012-05-31
K120944 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLERCovidien·Product code JOW·2012-05-31
K121023 — SPECTRUM V.0Intrinsic Medical Imaging·Product code LLZ·2012-05-31
K121307 — OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZExactech, Inc.·Product code JWH·2012-05-31
K121322 — CLOSER TO NATUREMayborn Group Limited·Product code HGX·2012-05-31
K121466 — GUIDEMIAGuidemia Technologies, LLC·Product code LLZ·2012-05-31
K111956 — KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITKronus Market Development Associates, Inc.·Product code PAF·2012-05-30
K112621 — WIS1000Foreseeson Custom Displays, Inc.·Product code GCJ·2012-05-30
K112859 — ERAPID NEBULIZER SYSTEMPari Respiratory Equipment, Inc.·Product code CAF·2012-05-30
K113402 — SOLOHEALTH STATIONSolohealth, Inc.·Product code DXN·2012-05-30
K113739 — SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEMMaterialise Dental NV·Product code LLZ·2012-05-30
K120084 — ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.·Product code OCZ·2012-05-30
K120170 — PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.·Product code HQE·2012-05-30
K120271 — ARTISAN SPACE MAINTENANCE SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code JEY·2012-05-30
K120395 — NERIA MULTI SUBCUTANEOUS INFUSION SETUnomedical Devices S.A DE C.V.·Product code FPA·2012-05-30
K120412 — 3M SPOTON TEMPERATURE MONITORING SYSTEMArizant Healthcare, Inc.·Product code FLL·2012-05-30
K120543 — TANDEMHEART FEMORAL ARTERIAL CANNULA SETCardiacassist, Inc.·Product code DWF·2012-05-30
K120574 — HAMILTON-C1Hamilton Medical AG·Product code CBK·2012-05-30
K120829 — STAINLESS STEEL SPINAL SYSTEMTheken Spine, LLC·Product code NKB·2012-05-30
K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDEBard Access Systems, Inc.·Product code IYO·2012-05-30
K121283 — BD EMERALD SAF-T SINGLE USE, HYPODERMICBecton, Dickinson and Company·Product code FMF·2012-05-30
K121340 — SOMNODENT G2Somnomed, Inc.·Product code LRK·2012-05-30
K110472 — SI-FIX SACROILIAC JOINT FUSION SYSTEMMedtronic Sofamor Danek·Product code OUR·2012-05-29
K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERHansen Medical, Inc.·Product code DXX·2012-05-29
K113561 — TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATIONZimmer Trabecular Metal Technology·Product code MAX·2012-05-29
K120360 — ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESISOrtho Solutions Limited·Product code HRS·2012-05-29
K121427 — UNIMED TEMPERATURE PROBEUnimed Medical Supplies, Inc.·Product code FLL·2012-05-29
K110074 — HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEMHealth & Life Co., Ltd.·Product code NBW·2012-05-25
K111049 — MOBILE VERSA LIGHTMedtek Lighting Corp·Product code FTC·2012-05-25
K111941 — CHOYANG THERMAL MASSAGERChoyang Medical Instrument Co., Ltd.·Product code JFB·2012-05-25
K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSebia·Product code GKA·2012-05-25
K112915 — SPIRTIUS CUFF INFLATION SYRINGESpiritus Technologies, LLC·Product code BSK·2012-05-25
K113006 — I-FUSE HAMMER TOE SYSTEMSOrthopro, LLC·Product code HWC·2012-05-25
K113696 — OPTOS ADVANCEOptos Plc.·Product code NFJ·2012-05-25
K113714 — VPAP TXResmed, Ltd.·Product code MNS·2012-05-25
K113801 — VPAP ADAPTResmed Corp·Product code BZD·2012-05-25
K120080 — SHASER HRS2 HAIR REMOVAL SYSTEMShaser, Inc.·Product code ONF·2012-05-25
K120275 — SYNTHES ACIS/VERTEBRAL SPACER CRSynthes (Usa), LLC·Product code ODP·2012-05-25
K120333 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYGambro Renal Products·Product code KPO·2012-05-25
K120587 — AMT T-FASTENER ANCHOR KITApplied Medical Technology, Inc.·Product code KGC·2012-05-25
K120604 — K-LASEREltech S.R.L·Product code ILY·2012-05-25
K120612 — MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNTMedtronic, Inc.·Product code DWF·2012-05-25
K120631 — PATIENT MONITORAdvanced Instruments, Inc.·Product code MHX·2012-05-25
K120899 — RANGE SPINAL SYSTEM, UNIT RODK2m, Inc.·Product code MNI·2012-05-25
K120964 — UPSTREAM GR CATHETERUpstream Peripheral Technologies·Product code DQY·2012-05-25
K121039 — COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock Technologies·Product code JTW·2012-05-25
K121380 — WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORTTeleflexmedical, Inc.·Product code GCJ·2012-05-25
DEN120012 — CDC DENV-1-4 REAL TIME RT-PCT ASSAYCenters for Disease Control and Prevention·Product code OZB·2012-05-24
K110644 — PRAEZIS PLUSTatramed Spol. S.R.O.·Product code HAW·2012-05-24
K112165 — RHEA CUPApex Medical Technologies, Inc.·Product code HHE·2012-05-24
K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2Sebia·Product code GKA·2012-05-24
K112585 — TOUAREG CLOSEFIT DENTAL IMPANT SYSTEMAdin Dental Implants System, Ltd.·Product code DZE·2012-05-24
K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEMBiomet Orthopedics, LLC·Product code MBF·2012-05-24
K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH·Product code BTO·2012-05-24
K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERVentlab Corp.·Product code CAP·2012-05-24
K120150 — DUAL SPIKE TRANSFER DEVICEB.Braun Medical, Inc.·Product code LHI·2012-05-24
K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc.·Product code MTD·2012-05-24

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