BEUDAMED
    24 results · 22ms · Sources: EU EUDAMED, US FDA

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    Biograph mMR with syngo MR E11P-AP01 system software

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIS Beveled Screw

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222839·MIS Screw 4mm Driver

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619027780·Dual Port 3ml Squeeze Flush Set Up w/4-Way Stop...

    Zodiac

    FDA UDI
    ALPHATEC SPINE, INC.·00844856001749·CP TI STRAIGHT ROD 5.5DIA X 130MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114179·KRATZ POLISHER 23GA SIDE (PK/10)

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007428·SCANLAN® Multi-purpose Clamp

    NETLINK/NETSCAN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JELDENT BASIC LINE

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 22, 2025

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·May 25, 2016

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code DHA·December 13, 2020

    SYNCHRON LXI 725 CLINICAL SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·October 6, 2008

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 11, 2011

    EXPRESS® SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·July 1, 2013

    ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTC·September 8, 2015

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON SARL A JOHNSON & JOHNSON CO.·Product code FTL·September 13, 2002

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·March 15, 2021

    ANEURX STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·May 13, 2016

    Brilliance ICT SP Computed Tomography X-ray system, Model 728311

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018