BEUDAMED
    16 results · 24ms · 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 ×

    BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707012023·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 6

    ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)

    FDA 510(k)
    FDA Class 2 ·Radiology

    BELLATEK® ABUTMENT TSV 3.5MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 26, 2026

    ABUTMENT, PATIENT SPECIFIC, TITANIUM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 3, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    FUJIFILM BALLOON BS-4

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDA·January 14, 2021

    MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand

    FDA Recall
    Terminated ·Microvision Medical Holding B.V. Meibergdreef 45 Amsterdam Netherlands·Product code FSO·July 21, 2006

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

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