BEUDAMED
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    EXTRACORP.'S INTERSEPT CUS. TUBING PK.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950019939·HOOK ROWE'S BOAT 6-1/4" 16CM

    NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN

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

    VALVULOTOME BY KOVEN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·October 22, 2012

    FREESTYLE FLASH

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

    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014

    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014

    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