BEUDAMED
    24 results · 20ms · Sources: EU EUDAMED, US FDA

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    EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5.5 EXP VERSE UNITIZED SET SCR

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    5.5 EXP VERSE SCR 6.0X45

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010037893·DRILL JIG FOR USE WITH 2.0MM TWIST DRILL

    Axiom®

    FDA UDI
    AXIOM MEDICAL, INCORPORATED·M6651111360·Thoracic Catheter, Right Angle, Silicone

    RINGLOC INSTRUMENTATION

    FDA UDI
    Biomet Uk Ltd·05019279414932·

    FISIO CHAMBER SPACE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEX FIXATION PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Widex

    FDA UDI
    Widex A/S·05706069885880·WIDEX MOMENT MRB0 (Deep Blue ) 110, RIC 10

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 14, 2013

    COBE SPECTRA BLOOD COLLECTION

    FDA Adverse Event
    Death ·TERUMO BCT·Product code GKT·September 23, 2014

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·May 26, 2011

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025