BEUDAMED
    21 results · 28ms · 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 ×

    AURORA

    FDA 510(k)
    FDA Class 2 ·Dental

    Trulife

    FDA UDI
    Trulife Limited·00645517612638·ActiveFlow External Breast Form Size 03

    HGB Controls - High

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498002360·A single level reference control intended for u...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190554·A/P Sizing and Distal Cutting Block 7deg Drill ...

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600030·Tray Insert, Level 3

    APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMAGECHECKER-CT WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·March 26, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 11, 2011

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·June 18, 2008

    SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 21, 2021

    ARROW AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DSP·November 9, 2023

    ARROW AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DSP·December 18, 2023

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DSP·November 16, 2015

    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·September 27, 2011

    AC3 OPTIMUS IABP NA/EMEA

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DSP·June 30, 2023

    AUTOCAT 2

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DSP·September 23, 2016

    OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·January 13, 2003

    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