BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ISOLATION GOWNS

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

    Colonic Irrigation Kit

    FDA UDI
    CLEARWATER COLON HYDROTHERAPY, INC.·B4249224420·Bulb Style Small Speculum Kit ~ 1/4 inflow hose...

    BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025

    BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025

    BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025

    POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEPUY CTA REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 26, 2024

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 3, 2014

    ADVANCE(R) TOT COND FEMORAL NON-POROUS

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JWH·January 18, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 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