27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InterActive Complete Surgical Tray
FDA 510(k)
FDA Class 2
·General Hospital
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508567·
LEONE SPA
FDA UDI
LEONE SPA·08033707011415·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 19
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GAMMA-B 1,25-DIHYDROXY VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 28, 2011
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
ENCORE SYSTEM
FDA Adverse Event
Injury
·SIESTA MEDICAL INC.·Product code ORY·September 25, 2014
ELEVATE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·July 8, 2020
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 29, 2020
DYB INTRODUCER, CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 12, 2025
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·April 25, 2019
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 12, 2018
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 19, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020