BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G-FORCE TI SUTURE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STENT SUPPORT GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 23, 2014

    5 FR S/L POWERPICC WITH SAFETY MI IN UPFT

    FDA Adverse Event
    Malfunction ·C. R. BARD, INC. (BASD)·Product code LJS·May 26, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 18, 2015

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

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

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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024