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

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    NEOPIP INFANT RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tru-Paque

    FDA UDI
    Taub Products·D8370720210·Masks out metal partial framework, veneers, cop...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215022983·

    HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE

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

    VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·STRYKER NEUROVASCULAR-CALIF·Product code NJE·April 22, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 20, 2011

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    FDA Enforcement
    Class I ·Terminated·E25Bio, Inc.·February 16, 2022

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·September 17, 2021

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·September 17, 2021

    1030489-2021-00686

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·May 24, 2021

    ATELLICA IM SARS-COV-2 TOTAL (COV2T)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code QKO·May 13, 2021

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·September 17, 2021

    CardioTek EP-TRACER Software V2.x.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·June 29, 2022

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

    FDA Enforcement
    Class III ·Ongoing·Sentinel CH SpA·July 14, 2021