BEUDAMED
    21 results · 30ms · Sources: EU EUDAMED, US FDA

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    SPAPLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bur PM2-125 80K Steel Ø3.1 St

    FDA UDI
    Bien-Air Surgery SA·17630055504101·

    Bur PM2-125 80K steel Ø3.1mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711004550011·

    GLOVER DEBAKEY BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921004550·GLOVER DEBAKEY BULLDOG CLAMP STRAIGHT

    GLOVER DEBAKEY BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896090194·GLOVER DEBAKEY BULLDOG CLAMP STRAIGHT TIP

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450054895·

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001201·Invue Max, Two Level ACP, 55mm

    GETTIG GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIOMET COMPREHENSIVE TOTAL SHOULDER REPLACEMENT

    FDA Adverse Event
    Injury ·BIOMET·Product code KWS·December 8, 2017

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 8, 2013

    LOCKING SCREW VARIAX FULL THREAD 2.7MM / L14MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA SELZACH·Product code HRS·September 19, 2014

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 17, 2011

    GALAXY G3 XSFT 4MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

    GALAXY G3 MINI 2.5MM X 3.5CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

    GALAXY G3 MINI 3MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

    GALAXY G3 MINI 2.5MM X 3.5CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021