13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endiscope, Endiscope Cervical
FDA 510(k)
FDA Class 2
·Orthopedic
VIDAS RUB IGG
FDA 510(k)
FDA Class 2
·Microbiology
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 15, 2014
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 29, 2011
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 20, 2013
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 6, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 15, 2020
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 9, 2023
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·December 6, 2024
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019