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

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    Any-Com Seal

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668124031·NANO Engineered Diamond Knife 2.75mm ang

    BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·May 31, 2018

    COOL.CLICK 2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    HEARTSTART FR 3 ECG BASIC BUNDLE EUROPE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 14, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·September 22, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 2, 2013

    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

    FDA Enforcement
    Class II ·Ongoing·Spectranetics Corporation·December 25, 2024