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

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    MODEL 78850 OXYGEN MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FAAC-4 - UP Facilities - 4-Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588121673·FAAC-4 - UP Facilities - 4-Shelf Cabinet

    B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORP.·Product code MZI·January 15, 2014

    MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SOYALA SILKGEL FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 17, 2010

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code PHX·October 7, 2024

    Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024