BEUDAMED
    10 results · 31ms · 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 ×

    Certas Plus Programmable Valves

    FDA 510(k)
    FDA Class 2 ·Neurology

    BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IOGYN ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONTINUE TM SHELL WITH MULTI HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LZO·October 29, 2014

    OPTI-PLAST XT PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·August 15, 2011

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025