BEUDAMED
    21 results · 21ms · 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 ×

    LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810015821·K-FILES 25MM

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040093976·Maxima K-Files 25mm

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782022924·CC/ Opaque Dentine OD-C4

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0015821·CC/ Opaque Dentine OD-C4

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001582·artVeneer life lower anteriors, UCM, BL2

    Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000740·Scanlan® VASCU-STATT® II Plus s-use bulldog cla...

    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 5, 2012

    STREP A RAPID TEST STRIP (THROAT SWAB)

    FDA Adverse Event
    Death ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·March 11, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·January 26, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·August 12, 2014

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012