BEUDAMED
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    WISCONSIN DUAL-PHOTON BONE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Symmetry Par

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482126998·Symmetry® Scissors, Par, Straight, Razor Edge w...

    PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMPLICITY DISPOSABLE PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007

    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    ACCOLADE SR SL MRI (Model L310)

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