16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
Stingray LP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
Sklar®
FDA UDI
SKLAR CORPORATION·10649111150326·SKLARLITXD METZ-LAHY STR 4.5"
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
FDA 510(k)
FDA Class 2
·Anesthesiology
ROSS RU SKIN DISCONTINUITIES
FDA 510(k)
FDA Unclassified
·Unknown
INTIMA-II 20GAX1.16IN PRN SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·July 20, 2021
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
ACRYSERT DELIVERY SYSTEM
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·August 26, 2011
NOVASURE
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code MNB·July 5, 2013
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·May 15, 2024
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·January 26, 2024
CARELINK CONNECT APP ANDROID
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·April 14, 2023
CARELINK CONNECT APP ANDROID
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·December 19, 2023
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026