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

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    PANTHER OIS/R & V MODEL VERSION 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113812·PS-C Insert, Size 6 x 16mm

    Spine Innovation Interbody System

    FDA UDI
    SPINE INNOVATION, LLC·00817722020397·Expandable Implant 5° x 12mm W x 16mm H x 26mm L

    NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

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

    NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS

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

    FMP HIP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWA·May 15, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 26, 2014

    INSYNC MAXIMO

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

    FDA Enforcement
    Class II ·Terminated·SEPPIM SAS·November 13, 2013

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024