BEUDAMED
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    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I

    EUROIMMUN ANTI-SLA/LP ELISA(LGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADEPT 1064/755 LASER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·April 22, 2015

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·June 14, 2011

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015