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

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    AQANIFE

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

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304232990·

    DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTUM SPINAL SYSTEM, QUANTUM MIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 27, 2011

    ACCESS ACCUTNI REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

    BZO Strip Dip Card (300ng/ml)*, Item No. 100170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 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