243 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Balex bone Expander System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM
OnX - A1
FDA UDI
Sprintray, Inc.·00850039704086·Full arch provisional restoration for all-on-x ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041379·2.7mm Over Drill, Quick Release
OsteoMed
FDA UDI
OSTEOMED LLC·00845694073424·FPS 2.7mm Over Drill, Quick Release Sterile Qty 2
CALIBRATING MATERIAL, BUFFERS, STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Widex
FDA UDI
Widex A/S·05706069425222·Widex MENU ME-X ITE (Dark brown ) Telecoil, Vol...
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 22, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 14, 2026
IQUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014
SPEEDLOCK IMPLANT WITH INSERTER HANDLE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code MBI·June 27, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
EVERSENSE SENSOR
FDA Adverse Event
Injury
·SENSEONICS INC.·Product code SBA·December 8, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 3, 2024
GMK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 30, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 5, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 20, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 16, 2024
GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2024