BEUDAMED
    12 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    Single-use Video Pancreaticobiliary Scope, PB Digital Controller

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

    da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)

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

    PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    CAPTURE-R READY SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·March 8, 2012

    GLUMA DESENSITIZER

    FDA Adverse Event
    Injury ·HERAEUS KULZER, GMBH·Product code KLE·November 3, 2008

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 17, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·July 9, 2013

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·September 29, 2020

    Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 26, 2019

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026