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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ryno Lacer Wrist and Thumb Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357237944·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024040007·

    HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSTRAINED LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AF MONITOR PACKAGE STERI

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

    VERITAS COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·August 18, 2011

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWA·July 10, 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