11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ureteral Stent Systems, Biliary Drainage Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMERALD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
BD SYNAPSYS¿ VIRTUAL SERVER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JQP·February 5, 2019
BD SYNAPSYS¿ VIRTUAL SERVER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JQP·February 5, 2019
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·June 9, 2025
CRD FLEX ADVAN, BIG W/ M EDISTOP,1L 6MM, 180 CM
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code GCX·June 26, 2013
COLLEAGUE PRE P17
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
SENSORMEDICS
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 207, INC.·Product code LSZ·September 25, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018