BEUDAMED
    9 results · 20ms · 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 ×

    SYNTHES (USA) RATCHETING DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981275·anteriors; shade C2; mould BL2

    Symmetry Surgical®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482087527·Symmetry® Forceps, Spoon, Ratcheting Handle w/R...

    BOSTON SCIENTIFIC SURGICAL MESH

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

    CHLORIDE/CARBON DIOXIDE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·February 27, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·February 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 5, 2014

    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