ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF

FDA 510(k)

FDA Class 2 ·Orthopedic

Pulse Oximeter For Over-The-Counter Use

FDA classification

FDA Class 2 ·Pulse Oximeter For Over-The-Counter Use

Visby Medical Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

binx health io CT/NG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® liat CT/NG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

FDA 510(k)

FDA Class 2 ·Microbiology

BD CTGCTV2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas CTNG for use on cobas 6800/8800 systems

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther System)

FDA 510(k)

FDA Class 2 ·Microbiology

XENFORM SOFT TISSUE REPAIR MATRIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alinity m STI Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

FDA 510(k)

FDA Class 2 ·Microbiology

NeuMoDx CT/NG Assay 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

BVI SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Mycoplasma genitalium Assay

FDA 510(k)

FDA Class 2 ·Microbiology