BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    OSTEORAPTOR SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517054036·XLIF AMS Trial, 8x22mm 15° Lollipop

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517053794·XLIF AMS Trial, 8x22mm 15° Modular

    Harvard PremiumFlow B2

    FDA UDI
    Harvard Dental International GmbH·EHAR70822151·Flowable light cure nano-hybrid composite for r...

    QUIK-CHECK HOME PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ASAHI REXEED-LX SERIES DIALYZER

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

    3.5MM UNIVERSAL DRILL GUIDE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FZX·April 29, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2011

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 25, 2008

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015