BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    CeQur Simplicity™ On-Demand Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)

    LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS

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

    FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

    FDA 510(k)
    FDA Class 2 ·Radiology

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·March 19, 2020

    SL 1 INTRODUCER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011

    RESPONSE EP CATHETER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011

    LIGACLIP CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 11, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·September 1, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 26, 2012

    PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014