BEUDAMED
    10 results · 27ms · 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.
    Filters Regulation: Us FDA ×

    MC2P ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Imaging Plates

    FDA UDI
    PaloDEx Group Oy·06430035875016·STD IP-SET 2X6 DT-1

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746135828·DB BKT MASTER LR CUSP 018 T=0 A+3 R2D

    MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·November 23, 2020

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2014

    WALLFLEX¿ COLONIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code MQR·January 7, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·October 28, 2010

    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