201 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VX650
FDA 510(k)
FDA Class 2
·Ophthalmic
LEONE SPA
FDA UDI
LEONE SPA·08033707037071·DB BRACKETS 22 H/P LAT U
Mid America Energy - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588082219·Mid America Energy - 18 Metal
24M - Salt River Project-21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS NORTH AMERICA LLC·Product code MHX·April 14, 2022
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 9, 2022
630G INSULIN PUMP MMT-1715KL 630G
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2022
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 11, 2022
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 10, 2022
630G INSULIN PUMP MMT-1715KL 630G
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 26, 2022
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 3, 2022
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES, INC·Product code GCY·March 25, 2021
SERVO-U
FDA Adverse Event
Death
·MAQUET CRITICAL CARE AB·Product code CBK·February 24, 2023
SERVO-U
FDA Adverse Event
Death
·MAQUET CRITICAL CARE AB·Product code CBK·February 24, 2023
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 10, 2023
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 7, 2022
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 14, 2022
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 25, 2022