BEUDAMED
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    ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104286·Biomet 3i Certain®-compatible 4.1mm Straight Mu...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092130520·Biomet 3i Certain®-compatible 4.1mm Straight Mu...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756656245·60 CM PRESSURE MONITOR LINE F-M 25C

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361008767·PedFuse Respond, CNL, 9.0mm x 75mm

    V11-3EUltrasonic Transducer(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904087955·

    SERAGARD VASCULAR ACCESS PATCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEART 2005

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MaxTorque™

    FDA UDI
    TORNIER, INC.·00846832054237·

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KXA·March 13, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·February 25, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 19, 2008

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025