BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADSTREAM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013

    ENTERRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LNQ·March 30, 2011

    GAMMAMED PLASTIC NEEDLE WITH MANDRIN

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS·Product code JAQ·June 13, 2008

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015