BEUDAMED
    19 results · 23ms · 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 ×

    ENDOGATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SELECT SEED I-125

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURESET INFUSION SET, MODEL 8023

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ABBOTT NUTRITION - COLUMBUS·Product code LZH·May 3, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 2, 2011

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    ROD Ø5.5 SOFT CURV L70 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 5, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    ROD Ø5.5 SOFT CURV L70 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·November 6, 2013

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012

    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