14 results
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18ms
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Sources: EU EUDAMED, US FDA
OTS Hip
FDA 510(k)
FDA Class 2
·Neurology
Vivid ZirDisc Zircon Zahn System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500861·95x22mm 03HT (Translucent)
Pedo Series Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755895·Pedo Series Toothbrush, child ages 2-5, soft en...
ELMED
FDA UDI
ELMED INCORPORATED·00842180134812·5 MM DIA., 33 CM, LAP. MONOPOLAR SUCTION ELECTR...
Titan
FDA 510(k)
FDA Class 2
·Physical Medicine
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code MCX·April 30, 2026
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCX·April 30, 2026
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
ULTRAFLEX¿ ESOPHAGEAL NG
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·September 15, 2011
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·July 26, 2013
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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013