BEUDAMED
    15 results · 21ms · 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 ×

    VIS-U-ALL II HEAT-SEAL POUCH AND TUBING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    ADVANTAGE SERIES 26 OBS 10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·April 27, 2011

    GE OEC 2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008

    EASYLINK

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014

    IRIDEX IQ577 LASER SYSTEM

    FDA Adverse Event
    Injury ·IRIDEX CORP.·Product code GEX·November 4, 2013

    EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022