BEUDAMED
    11 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.

    PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771050190·Steinmann Pins, Double trocar threaded, 5/32-in...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704294125·

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771015543·Steinmann Pins, Double trocar threaded, 5/32-in...

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·August 10, 2023

    MYO-CHECK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Nihon Kohden CO2 Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 15, 2010

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·December 13, 2012

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024