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

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    SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE

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

    EP DEFLECTABLE CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 20, 2011

    UNK

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·August 19, 2008

    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