27 results
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31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Quantum TTC Biliary Balloon Dilator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
FDA 510(k)
FDA Class 2
·Ophthalmic
AMSCO CHIMERON SMALL STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 8, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·July 1, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 24, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 17, 2024
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·August 21, 2017
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 16, 2025
COULTER LH750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 22, 2008
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 29, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 29, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 8, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 25, 2022
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021