Data-driven Intelligence on the FDA

Devices@FDAzilla

Recent 510(k) Activity
DateDeviceCompanyProduct CodeApplication Number
2012-02-03BLUE PAPOOSE MODEL SBL60
PHYSICIAN ENGINEERED PRODUCTS, INC.LBIK110550
2012-02-03PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
PLAYTEX MANUFACTURING INC.HILK111684
2012-02-03REST ASSURED GENERATION III DENTAL PROTECTOR
RANIR LLCOBRK120103
2012-02-03CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
CHISON MEDICAL IMAGING CO., LTD.IYNK113359
2012-02-03AVEX CX, AND AVEX CXI CERAMIC BRACKETS
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC.NJMK113334
2012-02-02MINI-MEDIC
ATHENA GTXMWIK113165
2012-02-02FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
FRESENIUS MEDICAL CARE, NORTH AMERICAKDIK120017
2012-02-02APC FLASH-FREE ADHESIVE
3M UNITEK CORPORATIONDYHK113197
2012-02-02HERO GRAFT
HEMOSPHERE INCDSYK120006
2012-02-02RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
GREATBATCH MEDICALDYBK110051
Recent PMA Activity
DateDeviceCompanyProduct CodeApplication Number
2012-02-01HER2 CISH PHARMADX KIT
DAKO DENMARK A/SNYQP100024
2012-02-01VISTAKON (SENOFILCON A) BRAND CONTACT LENSES
VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CARLPMP040045
2012-02-01VISTAKON (ETAFILCON A) BRAND CONTACT LENSES
CONTACT LENSES		VISTAKONLPMN18033
2012-01-31INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
IMPLANTABLE SYSTEM FOR SACRAL NERVE STIMULATION		MEDTRONIC INC.EZWP970004
2012-01-31TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
TMJ MEDICALLZDP000023
2012-01-31TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
TMJ MEDICALMPIP000035
2012-01-31CELLPAKER PLASMA COLLECTION DEVICE
STRYKER CORP.LMFP050044
2012-01-31HIGH FREQUENCY OSCILLATING VENTILATOR
VENTILATOR		CAREFUSIONLSZP890057
2012-01-30INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
MEDTRONIC INC.EZWP080025
2012-01-27CYPHER SIROLIMUS-ELUTING CORONARY STENT
CORDIS CORPORATIONNIQP020026