BEUDAMED
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    CRYOLYZER ALPHA (CRYOSURG.EQUIP.)

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

    TRAY, BLOOD SAMPLING (PULSATOR II)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEWLIFE ELITE

    FDA Adverse Event
    Death ·AIRSEP CORP.·Product code CAW·April 10, 2014

    RELIANCE SYNERGY WASHER

    FDA Adverse Event
    STERIS CANADA CORPORATION·Product code LDS·September 26, 2012

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code NIP·July 14, 2010

    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

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025