VISIONLINK DICOM MODULE

FDA 510(k)

FDA Class 2 ·Radiology

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Zavation Z-Link Lumbar

FDA 510(k)

FDA Class 2 ·Orthopedic

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

LISTENAIDER II

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROEPG SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Zavation IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25

FDA 510(k)

FDA Class 2 ·Orthopedic

PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BASELINE CALIBRATION VERIFICATION CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

FLIPSCREEN QAT

FDA 510(k)

FDA Class 2 ·Immunology

EQUATE(TM) AQR APO AL/B DUO CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX EQUATE GLYCOHEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BinaxNOW™ COVID-19 Antigen Self Test; BinaxNOW™ COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: PSS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic