BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Patello-Femoral Wave (Kahuna) Arthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517567444·CoRoent Ant TLIF PEEK, 8x11x28mm 0°

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515025493·Kocher-Langenbeck Retr, 25x6mm, 8 1/2"

    V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT

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

    MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·June 21, 2013

    LC PCA NEW 802.11 AB

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·July 8, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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