BEUDAMED
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    JOURNEY UNICONDYLAR TIBIAL BASEPLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    tF Calibrated Reference Load 15cmH2O (2 Years Edition)

    FDA UDI
    Thorasys Thoracic Medical Systems Inc·07540261020698·2 year valid Reference Load (15 cm H2O.s/L) to ...

    VARIANT

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020690·Trial 26x32mm, 20° Lordotic, 13mm

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020690·SPIRA®-A Integrated,Trial, 28x38mm, 25° Lordoti...

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970010·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970027·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974018·UniTip High Resolution Catheter 10F

    ASCEND SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    AGX

    FDA UDI
    Widex A/S·05706069660982·Audigy AGXWU-FP (Summer gold ) Telecoil, Volume...

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 22, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 19, 2014

    HUDSON INCENTIVE SPIROMETER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BWF·April 13, 2011

    MICRUSPHERE XL 6MMX20CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·November 20, 2020

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021