BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    Medussa-PL Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Biomet® Cemented Cup Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868343421·

    BIOMET CEMENTED CUP HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304449664·

    GLYCA-DIRECT FRUCTOSAMINE

    FDA 510(k)
    FDA Class 2 ·Hematology

    Solevy Co. LLC Water-Based Personal Lubricant

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

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 25, 2011

    STRAIGHT BROACH HANDLE

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL SA·Product code LXH·August 5, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 12, 2013

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·March 27, 2024

    REGENEREX ACETABULAR SHELL 64ODX54ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 6, 2018

    36MM COCR BIOMET FEM HD -3 NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 23, 2018

    ARCOS HA MODULAR REVISION CONE PROXIMAL BODY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 6, 2018

    36MM COCR BIOMET FEM HD -3 NK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDG·August 27, 2018

    ARCOS STRAIGHT TAPERED SPLINED DISTAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·August 6, 2018

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FON·February 19, 2024

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

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

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

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