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

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    CNS-2101 Central Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STAT PROFILE PHOX PLUS L ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    TECNIS MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·August 25, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

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

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