BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    SUBTALAR PEG IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033046·Baltic Denture System BDLoad Sw7 PLSEbm6DFs D2 ...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position

    COSMOS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMAGE VASCULAR LASER

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

    NA

    FDA UDI
    Zimmer, Inc.·00889024114272·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2025

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013

    AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 29, 2011

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FMF·April 22, 2008

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·August 10, 2016

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013