27 results · 31ms · Sources: EU EUDAMED, 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