BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    I.M. BLADES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950022311·BAND PUSHER 6" 15CM

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399006806·

    MICROAIRE TRANSBLEPH 3.0

    FDA Adverse Event
    MICROAIRE SURGICAL INSTRUMENTS·Product code HWC·May 13, 2016

    RENEGADE HI-FLO MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DHS®/DCS® COUPLING SCREW

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWB·December 11, 2018

    UNKNOWN DEPUY 7-DEGREE ADAPTER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.-1818910·Product code JWH·May 8, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code FTL·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    Endotine Transbleph 3.5 (CFD-080-0167)

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code HWC·May 6, 2016

    Endotine Transbleph 3.5 (CFD-080-0167)

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·August 3, 2016

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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