BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    FIBERNET EMBOLIC PROTECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premium Plus CEEA

    FDA UDI
    Covidien LP·10884523006605·Circular Stapler

    COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED M-IV MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PREMIUM PLUS CEEA 28 MM

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GAG·October 2, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·May 14, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code FPA·June 2, 2011

    VAMP FLEX KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·August 12, 2008

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HSB·March 2, 2017

    BLADE/SCREW GUIDE SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code FZX·March 2, 2017

    ENDO CLIP II

    FDA Adverse Event
    Malfunction ·COVIDIEN MEDICAL PRODUCTS·Product code FZP·December 8, 2022

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

    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