HEMOCHRON JR. CITRATE APTT CUVETTE

FDA 510(k)

FDA Class 2 ·Hematology

MONOJECT PLASTIC DENTAL INJ. SYRINGE

FDA 510(k)

FDA Class 2 ·Dental

Revolution Ascend

FDA 510(k)

FDA Class 2 ·Radiology

BODYSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ODALYS Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT

FDA 510(k)

FDA Class 2 ·Neurology

CM00622 LINC Skin Closure System (CM00622 LINC)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CM005 Standard (CM005); CM004 Mini (CM004)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WELLCOGEN BACTERIAL ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

AGGLUTINATING SERUM W135

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOGEN N. MENINGITIDIS A,C,Y W135

FDA 510(k)

FDA Class 2 ·Microbiology

WILLCOGEN MENINGITIDIS KIT ZL25

FDA 510(k)

FDA Class 2 ·Microbiology

PHADEBACT CSF TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SLIDEX MENINGITE-KIT 5

FDA 510(k)

FDA Class 2 ·Microbiology

BACTIGEN-N. MENINGITIDIS

FDA 510(k)

FDA Class 2 ·Microbiology

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST

FDA 510(k)

FDA Class 2 ·Microbiology