BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    Sterile Posterior Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074362434·SCREW 7221745 HA COATED CANN 7.5 X 45

    G-Jet® Transgastric-Jejunal Feeding Device

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071102791·22FR x 1.7 cm x 45 cm Low Profile Transgastric-...

    G-Jet® Transgastric-Jejunal Feeding Device

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071117535·22FR x 1.7 cm x 45 cm Low Profile Transgastric-...

    VASCLIP

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

    MANTARAY GUIDEWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·October 1, 2015

    MECTALIF ANT - LAG

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

    NX3

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·November 7, 2008

    FINELINE II STEROX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DTB·August 16, 2011

    2.5X53MM DISC XS ULNA W/BC LT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDC·July 11, 2013

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017