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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ACTIVAT-PARTIAL THROMBO-PLASTIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435062179·MCD Screw 3.0 x 20 mm cannulated M2 partia...

    Auria™ T-Mic™

    FDA UDI
    Advanced Bionics, LLC·07630016808623·Small Beige

    Auria™ T-Mic™

    FDA UDI
    Advanced Bionics, LLC·00840094450585·Beige (small)

    WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 23, 2014

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 13, 2012

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2015

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025