BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Wrist Type Blood Pressure Monitor (W05,W1101L)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bow-Flex Wire

    FDA UDI
    TP ORTHODONTICS INC·00192029035986·Standard Arch Form ...

    Spinal Retractor

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896116245·Spinal Retractor With 60 Millimeter Deep Prongs

    THERMOTRACE CORE

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL SYSTEMS, INC·Product code FMT·May 30, 2024

    ALIVECOR HEART MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

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

    ACRYSOF TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 7, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·May 29, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·October 23, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·March 12, 2024

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025