BEUDAMED
    18 results · 19ms · 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.

    LYTENING 2Z LYTENING SYSTEM 31

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sterile C-Arm / mobile x-ray cover

    FDA UDI
    Spiggle & Theis Medizintechnik GmbH·04250381811948·one piece, 190 x 105 cm 10 pie...

    Clear Readers

    FDA UDI
    Diversified Products, Inc.·00037741290087·

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989022575·ASSY ORTHOS SGL 0LFM -10T X18 LR

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099649·DB BKT MASTER 6.0MM LANG UR CUSP 018 T-3 A+10 R=0

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869668187·MOSS VRS Ti Connector, lateral, circular head, ...

    MODIFICATION TO AUTOFUSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIGHTSPEED 2.0CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NATURA

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·December 9, 2019

    SPACELABS ARKON ANESTHESIA WORKSTATION

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE LTD.·Product code CBK·November 6, 2015

    SPACELABS ARKON ANESTHESIA WORKSTATION

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE LTD.·Product code CBK·August 17, 2015

    SPACELABS ARKON ANESTHESIA WORKSTATION

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE LTD.·Product code CBK·September 18, 2015

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·February 4, 2015

    CVC SET: 2-LUMEN 4 FR X 8 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQY·May 6, 2014

    ACTIVE KNEE

    FDA Adverse Event
    ADVANCED SURGICAL DESIGN AND MANUFACTURE·Product code JWH·December 19, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 16, 2010

    (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·March 9, 2016

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013