BEUDAMED
    13 results · 35ms · Sources: EU EUDAMED, US FDA

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    OSSTEM Implant System - Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131305411·SENSEI, BTE 13 WL 90 PPI

    AQUATINE EC ENDODONTIC CLEANSER

    FDA 510(k)
    FDA Unclassified ·Unknown

    EMM EQUIPMENT COVER-POLYTHYLENE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

    OXF DOMED LAT TIB TRAY SZ B-UK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 6, 2019

    REVEAL LINQ

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DSI·October 10, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026