16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Relivion
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Synthes GmbH·10886982151803·3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RE...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154014958·DRILL,1.2X50MM,WL 6MM,HEXAGON SHAFT
LOGICAL CATH LAB SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, ASD.·Product code DRS·October 3, 2008
NAVIAID ICVI-F,S,B,R DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUIMAGE SMARTGATE UPGRADE
FDA 510(k)
FDA Class 2
·Radiology
LOGICAL CATH LAB SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, ASD.·Product code DRS·October 2, 2008
LOGICAL CATH LAB SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, ASD.·Product code DRS·October 3, 2008
VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·October 24, 2008
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 8, 2011
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·July 8, 2013
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 6, 2024
EVAC 70 XTRA COBLATOR II
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GEI·August 30, 2018
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025