BEUDAMED
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    IMMUNOGLOBULIN M REAGENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Preat

    FDA UDI
    Preat Corporation·00842092172605·2.2mm Retention Caps--Orange (6-Pack)

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209115648·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306835186·Surgical Aspiration Handle, Luer Lock 5.5" x .75

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399006790·

    ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QuikClot Control+

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 8, 2014

    TENSION FREE VAGINAL TAPE

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

    FREESTYLE

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

    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

    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