123 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CarboClear Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020854·3.3mm Directional Laser Probe
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020052·3.3mm Directional Laser Probe
SideFire® Directional Laser Probe
FDA UDI
MONTERIS MEDICAL INC·00816589020595·3.3mm Directional Laser Probe
STICK-E-PADS
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007308·1.5"x 2.5" Oval Foam
MULTI-STRAP FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
AVANTE CURELIGHT
FDA 510(k)
FDA Class 2
·Dental
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
OMNILINK .018 STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code FGE·August 11, 2011
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 22, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·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
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