EpiWatch Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

WIELISA PR-3 ANCA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE

FDA 510(k)

FDA Class 2 ·Dental

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODULAR FEMORAL HEAD WITH OFFSET TRUNION

FDA 510(k)

FDA Class 2 ·Orthopedic

BD MAX CT/GC/TV, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Immunology

SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325

FDA 510(k)

FDA Class 2 ·Microbiology

BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SONDREX P.A.L. SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMBU RMT VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

KAR

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDICAM 900 INSUFFLATOR WITH ACCESSORIES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SONALIS

FDA 510(k)

FDA Class 2 ·Radiology

GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAVESTATE NEUROMONITOR

FDA 510(k)

FDA Class 2 ·Neurology

NANMA ADJUSTABLE CONSTRICTION RING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAICHEM BUN RATE REAGENT (LIQUID)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIRECTIGEN NEISSERIA MENINGITIDIS TEST

FDA 510(k)

FDA Class 2 ·Microbiology