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

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    LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197621·AK3 PS-C Insert Trial Size 1, 10mm

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707035815·.019 X .025 Lower Stainless Steel Resilient Int...

    GRASPING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    QUALICHECK 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PREMIER ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

    Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 13, 2019

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 8, 2013

    CE INTERMATE SV 50, 48 PACK, 50125

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·February 16, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC MINIMED·Product code OYC·August 8, 2014

    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