BEUDAMED
    16 results · 20ms · 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 ×

    DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENSITITRE OPTIREAD

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FPA·November 21, 2018

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    FDA Adverse Event
    Malfunction ·INFUTRONIX LLC·Product code FPA·October 30, 2017

    CD HORIZON

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010

    DIMENSION XPAND PLUS WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·May 31, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 16, 2011

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·August 28, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020

    GALAFLEX

    FDA Adverse Event
    Injury ·TEPHA, INC·Product code OOD·February 28, 2020

    PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014