687 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LÖWENSTEIN LUISA VENTILATOR
FDA Adverse Event
Other
·LOEWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG·Product code QOT·August 25, 2023
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
Emergency Ventilator
FDA classification
FDA Not Classified
·Emergency Ventilator
DOT GMBH
FDA registration
DOT GMBH·19 products·🇩🇪 Germany
GOT SHADES INTERNATIONAL
FDA registration
GOT SHADES INTERNATIONAL·5 products·🇺🇸 United States
DOT AMERICA, INC.
FDA registration
DOT AMERICA, INC.·9 products·🇺🇸 United States
BOT IMAGE, INC.
FDA registration
BOT IMAGE, INC.·1 product·🇺🇸 United States
Leakbuster
FDA UDI
Starplex Scientific Corp.·10840165500444·Specimen Container, 90 ml Wide Mouth, Orange Ca...
Leakbuster
FDA UDI
Starplex Scientific Corp.·10840165500383·Specimen Container, 90 ml, Orange Cap, Applied ...
Leakbuster
FDA UDI
Starplex Scientific Corp.·10840165500666·Specimen Container, 120 ml, Orange Cap, Applied...
Bot Image, Inc.
FDA UDI
Bot Image, Inc.·00860009082625·ProstatID™ MRI Diagnostic Aid for Prostate Canc...
Bot Image, Inc.
FDA UDI
Bot Image, Inc.·00860009082618·ProstatID™ MRI Diagnostic Aid for Prostate Canc...
Bot Image, Inc.
FDA UDI
Bot Image, Inc.·00860009082601·ProstatID™ MRI Diagnostic Aid for Prostate Canc...
Dot Cup
FDA UDI
DOT INTERNATIONAL L3C·00860499001908·Menstrual Cup, medical grade silicone, non-late...
The Dot Printer Inc.
FDA registration
The Dot Printer Inc.·9 products·🇺🇸 United States
Alere Oratect
FDA UDI
Instant Technologies, Inc.·00817405020003·Drug screen test for detection of Methamphetami...
AOT EXTERNAL COMPRESS DEVICE
FDA 510(k)
FDA Class 1
·Orthopedic
BACK ON TRACK BOT LLC
FDA registration
BACK ON TRACK BOT LLC·3 products·🇺🇸 United States
RED DOT LED LIGHTING LIMITED
FDA registration
RED DOT LED LIGHTING LIMITED·1 product·🇨🇳 China
AOT & T-L Abutment
FDA 510(k)
FDA Class 2
·Dental