154 results · 22ms · Sources: EU EUDAMED, 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