25 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PowerLook Density Assessment V4.0
FDA 510(k)
FDA Class 2
·Radiology
16PW - Krispy Kreme FAK - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857308008·Parallel Rasp Size: 18x45x11 mm
OMNILINK .035 BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELECSYS PRECICONTROL VARIA 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 30, 2024
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·October 17, 2008
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 15, 2011
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·July 8, 2013
AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·July 23, 2025
AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 29, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·April 8, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·April 9, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·March 31, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 27, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
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