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

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    Hystero-V Hysteroscope

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 17, 2011

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 18, 2010

    X-FLOW PROSTATECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·April 17, 2024

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 8, 2008

    EEA XL 21MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·August 5, 2011

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MTF·July 2, 2013

    SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 18, 2010

    EXCOR®

    FDA Adverse Event
    Injury ·BERLIN HEART GMBH·Product code DSQ·November 27, 2024

    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

    FDA Recall
    Terminated ·Loma Vista Medical·Product code OZT·March 18, 2013

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 7, 2025

    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

    FDA Enforcement
    Class II ·Terminated·Loma Vista Medical·July 3, 2013

    MEDTRONIC ICD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·December 20, 2024

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·December 20, 2024