BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE

    FDA 510(k)
    FDA Unclassified ·Unknown

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809848632·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...

    Able Medical Devices

    FDA UDI
    J.M. Longyear Manufacturing, LLC·00810071391446·Temporary Fixation Pin

    ICE

    FDA 510(k)
    FDA Class 2 ·Dental

    SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    G2 FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 21, 2007

    G2 FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·May 15, 2007

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    RECOVERY G2 FILTER SYSTEM - JUGULAR DELIVERY KIT

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 23, 2010

    AMPLATZ SUPER STIFF GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·April 11, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 13, 2011

    DBS LEAD (WITH STIMLOC KIT)

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 22, 2008

    OXF ANAT BRG RT LG SIZE 3 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·December 19, 2023

    G2 FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 21, 2007

    OXFORD PH3 CEMENTLESS FEM SZ L

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·December 19, 2023

    HAHN TAPERED IMPLANT Ø3.5 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 15, 2021

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012