BEUDAMED
    14 results · 23ms · 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 ×

    BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717103544·Midway Select Disposable Diamonds 856-016F Pkg/25

    C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES

    FDA Adverse Event
    Injury ·3M UNITEK·Product code DYH·May 9, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 25, 2013

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·March 11, 2011

    UNK ZIMMER SEGMENTAL KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 27, 2008

    ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDINOL LTD.·Product code NIQ·April 7, 2021

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 16, 2020

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 16, 2020

    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014