126 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
FDA 510(k)
FDA Class 2
·Radiology
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020038·3.3mm Directional Laser Probe
STICK-E-PADS
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850689007381·2"x 3.5" Foam, Case of 10
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020779·3.3mm Directional Laser Probe
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020557·3.3mm Directional Laser Probe
STICK-E-PADS
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007384·2"x 3.5" Foam
BIO-LOGIC SLEEPSCAN NETLINK
FDA 510(k)
FDA Class 2
·Neurology
RENEGADE STC 18 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXCERA BASE
FDA Adverse Event
Malfunction
·ENVISIONTEC GMBH·Product code EBI·November 10, 2021
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
FDA Enforcement
Class II
·Terminated·Monteris Medical Corp·November 26, 2014
BIO-MED DEVICES
FDA Adverse Event
Malfunction
·BIO-MED DEVICES, INC.·Product code BZR·July 22, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·July 3, 2013
HF UNIT "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·November 19, 2023
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·July 8, 2022
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·October 18, 2022
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·October 24, 2022
HF UNIT "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH: BERLIN·Product code GEI·August 14, 2023
HF UNIT "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·August 27, 2021
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·July 15, 2022