BEUDAMED
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    Ova+ (K-OVAP-USA)

    FDA 510(k)
    FDA Class 2 ·Neurology

    OrthoGold 100

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

    FAST THROW STAINLESS STEEL SURGICAL SUTURE

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

    ACCU-CHEK COMPACT TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·November 6, 2008

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·July 20, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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