29 results · 23ms · Sources: EU EUDAMED, 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