510K & PMA Search:

Latest 510K and PMAs

Recent 510(k) Activity
DateDecisionDevice ApplicationCompanyProduct Code
2013-5-9VARIANT(TM) II TURBO HBA1C KIT - 2.0 :: K130990BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISIONLCP
2013-5-8MEDLINE BLOOD PRESSURE TRANSDUCER :: K123095MEDLINE INDUSTRIES, INC.DRS
2013-5-8SOL-CARE SAFETY NEEDLE :: K123684SOL-MILLENNIUM MEDICALFMI
2013-5-7HOVEROUND TEKNIQUE :: K122741HOVEROUND CORP.ITI
2013-5-7UNITRON TINNITUS MASKER FEATURE :: K130494UNITRON HEARINGKLW
2013-5-7HOVERROUND TEKNIQUE :: K122707HOVEROUND CORP.ITI
2013-5-7TEPHAFLEX MELTBLOWN CONSTRUCT :: K130326TEPHA, INC.OOD
2013-5-7CONI :: K130624GLOBALMEDLLZ
2013-5-7LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT :: K123368HARTALEGA SDN BHDLYY
2013-5-7ABL90 FLEX :: K123748RADIOMETER MEDICAL APSCHL
2013-5-7PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) :: K131009PROTEUS DIGITAL HEALTH, INC.OZW
2013-5-7DILATOR TUBE SET :: K120590KOROS USA, INC.PDQ
2013-5-7PUREFLUX-H HEMODIALYZER :: K122343NIPRO MEDICAL CORPORATIONKDI
2013-5-7FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE :: K122064TIANJIN NEW BAY BIORESEARCH CO., LTD.DJG
2013-5-6ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE :: K121702ORTHO MEDICALILX
Recent PMA Activity
DateDecisionDevice ApplicationCompanyProduct Code
2013-3-8VIDAS TOTAL PSA :: P040008BIOMERIEUX, INC.MTF
2013-3-7PUNCTUA CRT-D, COGNIS CRT-D, ENERGEN CRT-D, INCEPTA CRT-D :: P010012BOSTON SCIENTIFIC CORPORATIONLWP
2013-3-7CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D), PUNTUA CRT-D, COOGINS, ENERGEN CRT-D, INCEPTA CRT-D :: P010012BOSTON SCIENTIFIC CORPORATIONLWP
2013-3-7BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM) :: P010031MEDTRONIC CRDM
2013-3-7BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D :: P010031MEDTRONIC CRDM
2013-3-7BRAVIA CRT-D, VIVA S CRT-D, VIVA XT CRT-D :: P010031MEDTRONIC CRDM
2013-3-7NAVISTAR :: P040036BIOSENSE WEBSTER, INC.LPB
2013-3-7LINX REFLUX MANAGEMENT SYSTEM :: P100049TORAX MEDICALLEI
2013-3-7CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM :: P110042CAMERON HEALTH, INCLWS
2013-3-7CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER :: P950005BIOSENSE WEBSTER, INC.LPB
2013-3-7PUNCTUA ICD, TELIGEN ICD, ENERGEN ICD, INCEPTA ICD :: P960040BOSTON SCIENTIFIC CORPORATIONLWP
2013-3-7ADVISA MRI :: P980035MEDTRONIC CRDMNVZ
2013-3-7NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER :: P990025BIOSENSE WEBSTER, INC.LPB
2013-3-7STOCKERT 70 RADIOFREQUENCY GENERATOR :: P990071BIOSENSE WEBSTER, INC.LPB
2013-3-7PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBTILLATOR, TELIGEN IMPLANTABLE CARIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARDI :: P960040BOSTON SCIENTIFIC CORPORATIONLWP