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

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    NEO-PREGNOSTICON DUOCLON TUBE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CAPNOMASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OPTIBOLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS 8000 C702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 11, 2025

    RECEPTAL CANISTER 1000 ML CE

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012

    RECEPTAL 1.5LITER PE/CE WITH (50/CASE)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·August 1, 2011

    NON-PVC RECEPT LINER 2000ML/CE(50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

    NON-PVC RECEPT. LINER 2000ML/CE(50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

    NON-PVC RECEPT LINER 2000ML/CE(50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

    RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)

    FDA Adverse Event
    Injury ·HOSPIRA LTD.·Product code GCX·November 18, 2010

    RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

    RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 14, 2012

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 25, 2007

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 24, 2014

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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