BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    SHARPSTANK REUSABLE SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sasmar Vanilla

    FDA UDI
    Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT

    REPROCESSED RESTEP COMPRESSION SLEEVES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EDWARDS INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·March 16, 2018

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 16, 2018

    FX OXY W/HR & ART FILTER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION ASHITAKA·Product code DTZ·May 22, 2013

    CAPSURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·August 20, 2008

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 29, 2014

    AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    FDA Enforcement
    Class II ·Terminated·AMS Diagnostics, LLC·April 2, 2014

    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