BEUDAMED
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    PATIENT SAFE LUER CAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111370700·MICRO TRAY 8 X 14 X 1 1/8"

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450232255·

    PROFOX SOFTWARE, MODEL 920M-41

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO WARTNER WART REMOVAL SYSTEM

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

    HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 30, 2021

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·April 30, 2013

    BIODESIGN ANTERIOR PELVIC FLOOR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·August 28, 2014

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 11, 2011

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 8, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 6, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 26, 2021

    TL+ TELESCOPIC LINEAR DISTRACTOR 100MM

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code LXT·October 5, 2016

    TL+ TELESCOPIC LINEAR DISTRACTOR 100MM

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code LXT·October 5, 2016

    TL+ TELESCOPIC LINEAR DISTRACTOR 100MM

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code LXT·October 5, 2016

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·March 9, 2016

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021