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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 3, 2022
PORTABLE X-RAY UNIT, MATRIX S GX-101
FDA 510(k)
FDA Class 2
·Radiology
Portux 3D Printing Resin SG x 1000g
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126901211·Portux 3D Printing Resin SG x 1000g
Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
FDA classification
FDA Class 2
·Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
TiLite
FDA UDI
Tilite·00853316008075·
CGX, LLC
FDA registration
CGX, LLC·2 products·🇺🇸 United States
DRILL GUIDE EXTENSION
FDA UDI
Biomet Orthopedics, LLC·00887868074950·
FGX Canada Corp
FDA registration
FGX Canada Corp·2 products·🇨🇦 Canada
FGX EUROPE Ltd
FDA registration
FGX EUROPE Ltd·2 products·🇬🇧 United Kingdom
PGX PLATINUM HEALTH
FDA registration
PGX PLATINUM HEALTH·1 product·🇺🇸 United States
FGX International Limited - China
FDA registration
FGX International Limited - China·3 products·🇨🇳 China
Coalition AGX Plate and Coalition AGX Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
IMD 7GX
FDA 510(k)
FDA Class 1
·Dental
SpiraBrush CX
FDA UDI
HISTOLOGICS, LLC·00860275000309·SpiraBrush CX is intended for obtaining a biops...
3M™ Precise™
FDA UDI
3M COMPANY·30707387081899·3M™ Precise™ Disposable Skin Stapler, Pistol-Gr...
3M™ Precise™
FDA UDI
3M COMPANY·30707387070190·3M™ Precise™ Disposable Skin Stapler, Pistol-Gr...
AGX
FDA UDI
Widex A/S·05706069750164·Audigy AGXWU-IM (Light beige S-330 ) Left
AGX
FDA UDI
Widex A/S·05706069748734·Audigy AGXWU-FA (Midnight black S-440 ) Telecoi...
AGX
FDA UDI
Widex A/S·05706069669183·Audigy AGXWD-CIC (Light beige ) Left, RC coil, ...
AGX
FDA UDI
Widex A/S·05706069719659·Audigy AGXWU-IP (Dark brown ) Left