BEUDAMED
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    MH1 MICROHOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964072628·The ENDO CARRY-ON Procedure Kit contains all of...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111019968·PLASTIC PRCDURE TRAY HVYDTY PF

    GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES CERVIFIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2024

    NI

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 29, 2020

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    OSSEOTITE TAPERED CERTAIN PREVAIL MPLANT 4/3 X 10MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 26, 2022

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 26, 2022

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 26, 2022

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 9, 2013

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 15, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·May 18, 2011

    MEMORY II DOUBLE LUMEN EXTRACTION BASKET

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code LQR·July 28, 2021

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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

    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

    Model Number L210 PROPONENT SR SL Pacemaker

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