NOVA LITE ENDOMYSIAL

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY SCREEN FLOURESC

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-ENDOMYSIAL ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

NEUROTECH RECOVERY

FDA 510(k)

FDA Class 2 ·Neurology

ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANTIGENZ CHLAMYDIA

FDA 510(k)

FDA Class 2 ·Neurology

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

FDA 510(k)

FDA Class 2 ·Dental

BOBES TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

BOBES SLIT LAMP

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic