BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    PERCUSSIVETECH HF, MODEL 2001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981726·anteriors; shade BL2; mould US4

    Medline Patient Cables and Lead Wires

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TYSONBIO LINK HEALTH MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GFA·February 27, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 8, 2011

    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019