iTEAR Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

iTEAR100 Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

Electromechanical Tear Stimulator

FDA classification

FDA Class 2 ·Electromechanical Tear Stimulator

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

JOSTRA VENT CATHETERS, MODELS LV & HKV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Precision Flow® HVNI

FDA 510(k)

FDA Class 2 ·Anesthesiology

F&P Airvo 3

FDA 510(k)

FDA Class 2 ·Anesthesiology

cobas vivoDx MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

HVT 2.0

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MODEL HM4 LITHOTRIPTER CHANGE KV SETTING

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

CERVEX-BRUSH COMBI

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Obstetrical Kit

FDA classification

FDA Class 2 ·Obstetrical Kit