BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515023703·Ribbon Retractor, 5/8" width, 6 3/4"

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L18095001K0·Cover Screw

    STIWELL MED4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 24, 2019

    LOCKING SCREW, FULLY THREADED 5X55 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 30, 2010

    AUTO LUBE SYSTEM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEI·October 17, 2014

    LEAD MODEL 303

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 22, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·June 20, 2013

    LOW PROFILE SELF-TAPPING BONE SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 9, 2018

    M2A TAPER UNIVERSAL ALTERNATE BEARING SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·October 10, 2017

    COLLARLESS BI-METRIC POROUS STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 10, 2017

    M2A TAPER LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·October 10, 2017

    BI-METRIC/X POR NC LAT 14X150

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 12, 2017

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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