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

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    Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Crown - B1

    FDA UDI
    Sprintray, Inc.·00850039704802·SprintRay Crown is a light-curable polymerizabl...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 17, 2020

    SIMPLICITY DISPOSABLE PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIRECT BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEUROPACE RNS SYSTEM

    FDA Adverse Event
    Injury ·NEUROPACE, INC.·Product code PFN·December 1, 2021

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 16, 2017

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NVN·January 13, 2014

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 28, 2013

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    Y-90 THERASPHERE

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·July 17, 2024

    UNK - NAILS: PFN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·July 26, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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