154 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Eclipse DermaFlex Cannula
FDA 510(k)
FDA Class 2
·General Hospital
Paradigm
FDA UDI
Proprio, Inc.·00850042604205·Paradigm DRF Mini Clamp
ReLine
FDA UDI
Nuvasive, Inc.·00195377047007·RELINE-O Trial, 5mm H Lamina Ang N L-pop
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399000941·SMALL SAGITTAL SAW BLADE, 5.8mm X 18mm X 0.5mm
OptumSI Implant System
FDA UDI
SI Solutions, LLC·00850057247084·Blunt Dissector
Small Cannulated Screw Extractor AO
FDA UDI
Osteocentric Technologies, Inc.·00810074306263·Small Cannulated Screw Extractor AO
WANGENSTEEN TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059399·WANGENSTEEN TISSUE FORCEPS TUNGSTEN CARBIDE SER...
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur Anti-HBe2 (aHBe2) assay
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
FDA 510(k)
FDA Class 2
·General Hospital
MEDX 1000 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur Anti-HBe2 (AHBe2) Assay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Atellica® IM Anti-HBe2 Assay
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Atellica IM Anti-HBe2 (aHBe2)
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Atellica IM Anti-HBe2 (aHBe2)
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 3, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 12, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 8, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 16, 2025
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·March 30, 2026
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 11, 2026