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

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    CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636003·CoRoent Ant TLIF PEEK, 11x11x32mm 12°

    DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE

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

    JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    ISYMM ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Injury ·HOYA SURGICAL OPTICS INC.·Product code HQL·May 9, 2013

    AGC V2 INTERLOK TIB 10X 79MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·September 23, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·November 20, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·December 19, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 8, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 22, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·January 26, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·February 12, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Enforcement
    Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021