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