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

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    TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STARCAST DENTAL ALLOYS

    FDA 510(k)
    FDA Class 2 ·Dental

    TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 16, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    MITY VAC

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code HDB·August 14, 2008

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    TFNA FEM NAIL Ø11 R 130° L360 TIMO15

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·February 23, 2023

    40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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