BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    BIO-MINI REVO SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier SPRING PASTE FILLER

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053561·ROOT FILLER PKG 4 25MM 25

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844085·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE MEDIUM B...

    INVACARE PASSOVER HUMIDIFIER MODEL ISP9700

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIGHTSPEED 4.0 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165247·16mm X 13.5mm X 6mm, 7° Lordotic Trial/Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165278·16mm X 13.5mm X 9mm, 7° Lordotic Trial/Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165292·16mm X 13.5mm X 11mm, 7° Lordotic Trial/Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165285·16mm X 13.5mm X 10mm, 7° Lordotic Trial/Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165261·16mm X 13.5mm X 8mm, 7° Lordotic Trial/Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165308·16mm X 13.5mm X 11mm, 7° Lordotic Trial/Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165254·16mm X 13.5mm X 7mm, 7° Lordotic Trial/Broach

    TRILOGY EVO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·October 14, 2021

    SHELL POROUS WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 3, 2014

    TOTAL CARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 17, 2011

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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