BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

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    Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837105976·Static Expandable Cage Trial, 12mm x 28mm x 16m...

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

    METAFLEXCOIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BD PRESET¿ ECLIPSE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 13, 2024

    BD PRESET¿ ECLIPSE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 29, 2024

    BD PRESET¿ ECLIPSE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 14, 2024

    PENUMBRA SYSTEM MAX ASPIRATION TUBING

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LWP·June 7, 2013

    MYNX

    FDA Adverse Event
    Death ·ACCESSCLOSURE, INC.·Product code MGB·July 5, 2011

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018