BEUDAMED
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    MAGNETOM Vida

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780509776·Fine Stitch Scissors, 4-3/4", Straight, Sharp

    EK/P. AERUGINOSA PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEPUY ATTUNE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 21, 2013

    EON 16-CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 2011

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    INNOVA IGS 530

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021