29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSCAR 15
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100790·FLIERINGA FIXATION RING 18MM
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100820·FLIERINGA FIXATION RING 21MM
RHEAD RADIAL HEAD EXTENDED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 29, 2021
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 5, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 15, 2011
LINOX TD 65/18
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code LWS·September 18, 2008
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 27, 2022
ANEURX - UNK
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 8, 2025
ENDURANT II STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 8, 2025
ENDURANT II STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 8, 2025
ANEURX - UNK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 8, 2025
ACCUTRAK DELIVERY CATHETER SYSTEM
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 6, 2017
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 6, 2017
O-ARM IMAGING SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·September 30, 2024
UNKNOWN
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·September 30, 2024
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·September 30, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 17, 2025