15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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neoBLUE compact LED Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017835·K-Wire, Double Ended, Trocar Point, Diameter Si...
Precise
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657066730·Claw Forcep 10mm Single Action, 10mm, 45cm, Sta...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084882·K-Wire, Double Ended, Trocar Point, Diameter 0....
Precise
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657075701·Precise Claw Forcep, Single Action, 10mm 45cm ...
Precise
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657066747·Claw Forcep 10mm Single Action with Ratchet, 10...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084899·K-Wire, Double Ended, Trocar Point, Diameter 0....
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
FDA 510(k)
FDA Class 2
·Cardiovascular
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 10, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011
SUNBEAM
FDA Adverse Event
Malfunction
·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·September 8, 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