BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZMS®

    FDA UDI
    Zimmer, Inc.·00889024039834·

    IMDX VANR FOR ABBOTT M2000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LOGIC FEMORAL PS CEM RIGHT SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 13, 2024

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 4, 2014

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·August 25, 2011

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 10, 2013

    LOGIC TIBIA PS MOD INSRT SZ 3 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 13, 2024

    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