BEUDAMED
    17 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 ×

    ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LCP

    FDA UDI
    Synthes GmbH·10886982165930·3.5MM LCP-T-PLATE 4H HEAD/ 3H SHAFT/50MM-RIGHT ...

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704515244·

    PATHFINDER PLUS

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS·Product code LJS·January 13, 2025

    Arthrex Compression Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 10, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 26, 2024

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    BELLATEK¿ HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·February 18, 2025

    BELLATEK HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 18, 2025

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024