BEUDAMED
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    SMITH & NEPHEW PORPS & TORPS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM

    FDA 510(k)
    FDA Unclassified ·Unknown

    COAXIAL DILATOR SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RHK SEGMENTAL SHORT YOKE

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

    SUCTION/IRRIGATOR INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 13, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·February 27, 2008

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018