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

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    STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131262172·H11, RITE 312 WL TC

    XCELA

    FDA Adverse Event
    Injury ·PFM MEDICAL CPP SA·Product code LJT·October 24, 2024

    ARSTASIS DILATOR ADAPTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    HAKIM VALVE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·June 15, 2011

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·August 22, 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