BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    TRACHE-TITE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978084046·INSTRUMENT 950-930 ANT KERRISON RGR 3MM

    E.P.T. CERTAINTY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Deployable Oxygen Generation System-Smaill (DOGS-S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    S3 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

    3 TO 1 REDUCTION DRIVE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 14, 2011

    S3 ROLLER PUMP MODULE AND CONSOLE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR·Product code DTQ·March 24, 2010

    3-TO-1 REDUCTION DRIVE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHMAND·Product code DTQ·December 14, 2011

    STOCKERT S3 CONSOLE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

    STOCKERT S3 CONSOLE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

    ACCU-CHECK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·May 26, 2010

    TRIATHLON CR FEM COMP #8 L-CEM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·February 8, 2013

    LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 14, 2014

    SENSOR, LOW LEVEL II

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 16, 2010

    S3 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

    S3 ROLLER PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 22, 2010

    S3 ROLLER PUMP

    FDA Adverse Event
    SORIN GROUP DEUTSCHLAND·Product code DWB·October 12, 2016

    BLOOD CARDIOPLEGIA INSERTS

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·March 24, 2010

    XP-XP Tibial Tray - Interlok 67 mm Item # 195753

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014