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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM

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

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925014220·SHEA FLPL CP RT SM PIST

    AGXO

    FDA UDI
    Oticon A/S·05707131270030·H160, DESIGNRITE 10 WL CNB AGXO

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034305931·Cancellous Screw, Cannulated, D=4.0mm, L=22mm

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249288·PrimePadPlus-K14-3422

    SURGICAL STIMULATORS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODIFICATION TO VERTE-STACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-HINGE TIBIAL INSERT SIZE 1/17MM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KRO·November 10, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 31, 2013

    ACCENT SR RF OUS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 16, 2011

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

    MICRUSFRAME10 4MM X 7.5CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

    GALAXY G3 XSFT 2.5MM X 5CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

    GALAXY G3 MINI 1.5MM X 2CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 10, 2021

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 25, 2015

    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 25, 2019

    Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·November 14, 2019