126 results · 27ms · Sources: EU EUDAMED, 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