BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    CABLE SCREW WITH INTEGRAL CRIMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Rad-Sure™

    FDA UDI
    ASHLAND SPECIALTY INGREDIENTS G.P.·00810106410326·Blood Irradiation Indicator

    Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·April 14, 2021

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·February 20, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 5, 2014

    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.

    FDA Recall
    Terminated ·Theken Spine Llc·Product code KWQ·July 29, 2010