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

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    ZION Anterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821607020·ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180528785·Micro-Pituitary, 2 MM, Up

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180528792·Micro-Pituitary, 4 MM, Up

    STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS

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

    4CIS VANE SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUSCH GREENLED HANDLE, MEDIUM

    FDA Adverse Event
    Malfunction ·TRUPHATEK INTERNATIONAL LTD.·Product code CCW·April 10, 2018

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 30, 2011

    MWA PERCUTANEOUS ANTENNA 17CM

    FDA Adverse Event
    Malfunction ·Product code NEY·August 29, 2008

    SOLERA DRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·April 11, 2026

    RUSCH GREENLED HANDLE, MEDIUM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CCW·March 22, 2022

    SOLERA DRIVER 5.5/6.0 MAS

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·March 10, 2021

    LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

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

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018