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

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    TRANQUILL BARBED DEVICE

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

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS

    FDA UDI
    Bard Access Systems, Inc.·00801741010910·VACCESS PLUS, ST, 16 FR. 42cm

    Oticon

    FDA UDI
    Oticon A/S·05707131262165·H11, RITE 312 WL SIL

    NOYES IRIS SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896014589·NOYES IRIS SCISSORS STRAIGHT SHARP TIPS FLAT H...

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 20, 2021

    SYNGO, BREAST CARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    RNARETAIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    U-BLADE SET, TI GAMMA3 10.5X100MM

    FDA Adverse Event
    Injury ·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012

    PEN NDL 32G 4MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 16, 2021

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    4C -ES CELL CONTROL

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JPK·June 15, 2011

    INFANT BIAS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·August 22, 2008

    Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·October 10, 2012

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015