BEUDAMED
    15 results · 26ms · 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 ×

    REGENERX RINGLOC + MODULAR ACETABULAR SHELLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RINGLOC RIMCUP SHELL

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017

    MIH MOD CUP INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017

    Cordant

    FDA UDI
    Seaspine Orthopedics Corporation·10889981115340·69mm

    CLARIS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    ASR TAP SLV ADAP 12/14 -1

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016

    ALIF TRIAL SPACER ANGLED/LATERAL/ANTERIOR 9MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 22, 2013

    ACCU-CHEK ULTRAFLEX

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·April 18, 2011

    GE OEC STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012