BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304233065·

    MODIFICATION TO OPTICAL SEPARATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011

    C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016

    HIP END EFFECTOR, VARIABLE ANGLE

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·June 19, 2017

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 3, 2017

    PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. 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

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024