120 results · 25ms · Sources: EU EUDAMED, 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