123 results · 29ms · Sources: EU EUDAMED, 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