BEUDAMED
    14 results · 22ms · 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 ×

    RX IMOLA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106419·PERL CORNEAL FORCEPS 0.08MM LEFT

    RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    SONICWAVE SONIC PLAQUE REMOVER

    FDA 510(k)
    FDA Class 1 ·Dental

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·April 11, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 13, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·May 22, 2008

    BD SHARPS COLLECTOR 5.4QT RED

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 14, 2022

    SHARPS COLL NEXT GEN 5.4QT RED 20/PACK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·October 12, 2021

    HEARTMATE 3 SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·March 14, 2022

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·March 14, 2022

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 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