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

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    Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357239290·

    BEGOPAL+

    FDA 510(k)
    FDA Class 2 ·Dental

    MAGNETIC RESONANCE DIAGNOSTIC DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTICROSS?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·November 4, 2014

    ISOFLEX S

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

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·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