BEUDAMED
    10 results · 31ms · 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 ×

    SYNTHES ORACLE PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE-STEP PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    GAS RESPIRATION MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code BZK·April 30, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 10, 2011

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018