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

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    ROC LUMBAR PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMARA

    FDA UDI
    Respironics, Inc.·00606959014992·AMARA MASK WITH RS FRAME AND HEADGEAR, INTERNAT...

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776351359·Exodontia Oral Curette #13

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027971·

    GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

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

    ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND

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

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    BIPAP AUTOSV ADV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 10, 2022

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 15, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 16, 2011

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 22, 2019

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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