3,427 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Virage Navigation System
FDA 510(k)
FDA Class 2
·Neurology
Spex Limited
FDA UDI
SPEX LIMITED·09420051748156·Spex 2 Point Padded Hip Belt, Centre Pull, Easy...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120230·Screwdriver, Extended Tab, Fixed Tap Sleeve, As...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707191856·TruFit 2.0 018 MC UL6/7 NC SBT -14T 10Off DB SB...
Canal Reamer
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055837·
MIXJECT WITH SPRAY HEAD
FDA 510(k)
FDA Class 2
·General Hospital
ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 8, 2023
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 13, 2023
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 18, 2024
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 11, 2024
INSTANT HOT PACK
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code IMD·October 24, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 11, 2023
PUMP MMT-1880L MM770G BLE MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 10, 2023
PUMP MMT-1880L MM770G BLE MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 8, 2023
630G INSULIN PUMP MMT-1715K 630G BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 11, 2023
PUMP MMT-1880L MM770G BLE MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 7, 2023
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 2, 2023