BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDILOG EDITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMYLON (DENTAL STAIN ERASER)

    FDA 510(k)
    FDA Class 1 ·Dental

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 16, 2014

    QUICKSITE XL LV

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010

    ACCU - CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·December 5, 2012

    DOVER SILICONE FOLEY CATHETER TRAY

    FDA Adverse Event
    Malfunction ·SHERWOOD MEDICAL CO.·Product code KOD·November 15, 1995

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014