BEUDAMED
    16 results · 24ms · 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.

    TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450459669·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450445433·

    FLO ASSISTANT, MODEL 4-250-00

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

    MEDIFIX URETEROSCOPE

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

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014

    TPRLC 133 T1 PPS SO 12X144MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019

    ANTHEM RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 14, 2014

    AS3000 ANESTHESIA SYSTEM

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

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·May 4, 2011

    G7 HI-WALL E1 LINER 36MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·August 28, 2019

    CER OPTION TYPE 1 TPR SLEVE -6

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 28, 2019

    G7 OSSEOTI MULTIHOLE 58MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 28, 2019

    CER BIOLOXD OPTION HD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 28, 2019

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    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