BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    QUADRIPLEGIC URINARY DRAINAGE VALVE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    MİKRO

    Device
    EU MDR · Eu Md Class 1 ·SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ·On the market·32 countries

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 16, 2015

    ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FLEX-STAR V

    FDA 510(k)
    FDA Class 2 ·Dental

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 17, 2016

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 4, 2012

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·July 23, 2010

    GXL NUETRAL LINER, G0 28MM ID

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·March 15, 2024

    OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018