137 results · 21ms · Sources: EU EUDAMED, US FDA

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Neurosign V4 Intraoperative Nerve Monitor

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

SideFire® Directional Laser Probe

FDA UDI
MONTERIS MEDICAL INC·00816589020069·3.3mm Directional Laser Probe

SideFire® Directional Laser Probe

FDA UDI
MONTERIS MEDICAL INC·00816589020786·3.3mm Directional Laser Probe

SideFire® Directional Laser Probe

FDA UDI
MONTERIS MEDICAL INC·00816589020588·3.3mm Directional Laser Probe

PERCUSSIVENEB, MODEL PN-2001

FDA 510(k)
FDA Class 2 ·Anesthesiology

CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365

FDA 510(k)
FDA Class 2 ·Orthopedic

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

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026

ONE TOUCH PING METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·October 9, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

MO.MA. ULTRA 6F ID

FDA Adverse Event
Injury ·INVATEC SPA·Product code NTE·July 3, 2013

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024

HF UNIT "ESG-400"

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GEI·November 19, 2023

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023

ELECTROSURGICAL GENERATOR "ESG-400"

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GEI·July 8, 2022