120 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Disposable Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114117·SIMCOE CORTEX EXTR 23GA 0.4MM TXT PK/10
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020076·3.3mm Directional Laser Probe
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020830·3.3mm Directional Laser Probe
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020625·3.3mm Directional Laser Probe
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
FDA 510(k)
FDA Class 2
·Radiology
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
TIBIAL NAIL, STANDARD T2 TIBIA Ø9X270 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·February 12, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
INTELLIFLATOR
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code MAV·September 26, 2008
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
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022
ELECTROSURGICAL GENERATOR "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·October 5, 2022