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

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    THE FUGO BLADE FOR GLAUCOMA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NEUROTECH MEDISTIM PLUS, TYPE 291

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TI500 GLOBE-TROTTER TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    B100L BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON HUNGARY KFT (BD)·Product code FMF·June 8, 2017

    GMK TOTAL KNEE SYSTEM: TIBIA COMPONENT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·May 18, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KOG·August 6, 2014

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018