BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FIBONACCI™ PROXIMAL LATERAL TIBIA PLATE, LEFT, 2 HOLE

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665035179·

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113666·LOCATOR R-Tx Abutment for iSy Connection Implan...

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608860·MIDMARK 3.25" SOFTCARE PLUS

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114649·LOCATOR F-Tx Abutment for iSy Connection Implan...

    N20 RETINAL PRB STRAIGHT

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HQA·December 3, 2021

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189855·Patella Sizing Guide Body

    ELECTRODE SWITCHBOX, MODEL 11-081002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000

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

    WAKO LIPASE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 5, 2024

    NA

    FDA UDI
    Zimmer, Inc.·00889024065918·

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 21, 2025

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 26, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·May 4, 2016

    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·March 25, 2026