BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ARTHROTEK SET SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Nu-Edge Metal Bracket

    FDA UDI
    TP ORTHODONTICS INC·00192029046876·LL 2nd BI NO HK

    SPIWAY ENDONASAL ACCESS GUIDE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 29, 2013

    ENDOPATH** XCEL*

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·December 20, 2010

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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