BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277132901·Cheng Trephine 13mm

    HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ON-Q EXPANSION KIT: SILVERSOAKER 10 IN

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code BSO·May 15, 2013

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 3, 2013

    NONE

    FDA Adverse Event
    Malfunction ·INVACARE·Product code FNL·June 21, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    SEE H-10

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·June 30, 2015

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022