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

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    i-STAT G3+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PACEMAKER PACK

    FDA Adverse Event
    Malfunction ·AVID MEDICAL·Product code DTB·April 13, 2017

    PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DURABLUE STERILIZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 18, 2011

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·August 5, 2014

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 12, 2013

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026