BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    CARDIOPULMONARY BYPASS VASCULAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ComposiTCP

    FDA UDI
    S.B.M·03760154006897·Absorbable interference screw

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221113313·3M™ Victory Series™ Second Molar Bands, 905-224...

    INSITE STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAT FAX(TM)-2100

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 11, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 10, 2015

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 28, 2014

    ACCENT SR RF OUS

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 9, 2013

    REFLEX CATHETER

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·February 20, 2023

    NV MICROCATHETER

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·February 20, 2023

    PIPELINE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 20, 2023

    REFLEX CATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·February 20, 2023

    MARKSMAN

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·February 20, 2023

    NV MICROCATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·February 20, 2023

    MARKSMAN

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·February 20, 2023

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017