11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007
FDA 510(k)
FDA Class 2
·Radiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209132331·
TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
FDA 510(k)
FDA Class 2
·General Hospital
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 13, 2023
FORTIFY VR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 6, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 3, 2012
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 2, 2025
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 6, 2020
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025