BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Micro Skinner Forceps

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896118607·Micro Skinner Forceps With Stop Pin Delicate 1x...

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·04250307609949·Bipolar Probe, 130mm, bayonet

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·04250307609932·Bipolar Probe, 45mm, angled 30°

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327282221·Bipolar Probe 45mm, angled 30 degree

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·04250307609956·Bipolar Micro Fork Probe, 45mm, straight

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327282245·Bipolar Micro Fork Probe, 45mm straight

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327282207·Bipolar Probe 130mm, bayonet

    NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT

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

    VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RINGLOC-X E1 H/W 56/32MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·April 11, 2025

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014

    RADIAL JAW? 4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FCL·May 31, 2013

    GEM PREMIER 4000

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code MZV·June 16, 2011

    SonarMed AirWave Monitor, Model Number M0001

    FDA Enforcement
    Class II ·Terminated·SonarMed Inc·September 11, 2019

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·October 23, 2023

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026