BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Celerity Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

KT2000 KNEE LIGAMENT ARTHROMETER

FDA 510(k)

FDA Class 1 ·Physical Medicine

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

KT1000/S KNEE LIGAMENT ARTHROMETER

FDA 510(k)

FDA Class 1 ·Physical Medicine

Lumipulse B-Amyloid Plasma Controls

FDA registration

Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

Lumipulse B-Amyloid Plasma Controls

FDA registration

Fujirebio Inc.·1 product·🇯🇵 Japan

Lumipulse B-Amyloid Plasma Controls

FDA registration

Fujirebio Europe N.V.·1 product·🇧🇪 Belgium

Lumipulse B-Amyloid Plasma Controls

FDA registration

Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

Annalise Enterprise CXR Triage Trauma

FDA 510(k)

FDA Class 2 ·Radiology

Annalise Enterprise CXR Triage Trauma

FDA 510(k)

FDA Class 2 ·Radiology

ARCHITECT CA 19-9XR ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Annalise Enterprise CXR Triage Pneumothorax

FDA 510(k)

FDA Class 2 ·Radiology

Dental CT Scanner AXR

FDA UDI

Alliage S/A Indústrias Médico Odontológica·07899581335587·Tomography with Cephalostat (MFOV)

dicomPACS®DX-R

FDA UDI

Oehm und Rehbein GmbH·04250802900015·Professional acquisition software for the conne...

Lunit INSIGHT CXR Triage

FDA UDI

Lunit Inc.·08800076000124·

Dental CT Scanner AXR

FDA UDI

Alliage S/A Indústrias Médico Odontológica·07899581339639·Panoramic Mult Slice with Cephalostat (1 sensor)