10 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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EPi-Sense Guided Coagulation System with VisiTrax
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·10649111042119·VIRTUS SPLINTER FCP SERR ANG 6
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECSYS PTH CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·February 18, 2022
TRULIANT PS CEM FEM PS CEM LEFT SZ 5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 2, 2023
RSVR MMT-103A 10PK 3CC 13L STRL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·October 7, 2008
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code IXR·June 25, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016