BEUDAMED
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    ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VIDAS® TROPONIN I ULTRA

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code MMI·March 3, 2016

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020621·Cruciate Retaining Tibial Insert

    POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OSSEOTITE II MODEL XIFOSSXXX

    FDA 510(k)
    FDA Class 2 ·Dental

    BLUNT TIP SCREW, ÿ 4X48MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·April 29, 2025

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code GEI·August 21, 2025