BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    AuST Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776146658·Kite Shape Retractor elevator CVD Rotatable wit...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011251051400·ceraMotion® Ti Dentin C2, 40 g / dental ceramic...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011251051200·ceraMotion® Ti Dentin C2, 20 g / dental ceramic...

    Straumann BoneCeramic

    FDA 510(k)
    FDA Class 2 ·Dental

    Universa Soft Ureteral Stents and Stent Sets

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

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024497221·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024497214·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024497238·

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 29, 2013

    Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 29, 2019

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 8, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019