BEUDAMED
    27 results · 24ms · Sources: EU EUDAMED, US FDA

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    BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS

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

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481123634·LOCATOR R-Tx Attachment System, Straumann Tissu...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481123429·LOCATOR F-Tx Abutment for Narrow Neck Crossfit ...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128431·LOCATOR R-Tx Abutment, Straumann Tissue Level, ...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105040·Implant Inserter, 11-13mm, Sleeveless

    INFRARED EAR THERMOMETER, MODELS TH88 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANTA SUPER SOFT GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·April 3, 2013

    CONSTELLATION WITH LASER

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 18, 2011

    INDURA

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·May 9, 2008

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 3, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 1, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 23, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 12, 2017

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 2, 2014

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·July 10, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·April 25, 2018