BEUDAMED
    17 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.

    PLASMA COAGULATION CONT., ABNORMAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00147811040·2G Narrow A4

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111159039·TRACH RETR BLUNT 4 PRONG 6 1/2

    AESKULISA ANA HEP-2, REF 30-7115US

    FDA 510(k)
    FDA Class 2 ·Immunology

    Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 10, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2010

    Intera 1.5T Omni/Stellar, Model Number: 781104;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

    Intera 1.5T Omni/Stellar; Product Number: 781104;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·June 18, 2025

    Intera 1.5T Omni/Stellar, Model Number: 781104;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LNH·March 24, 2025

    Intera 1.5T Omni/Stellar; Product Number: 781104;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·May 29, 2025

    Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018

    Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·March 6, 2019

    Intera 1.5T Omni/Stellar, Magnetic Resonance System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 24, 2024

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LNH·March 16, 2018

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018