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

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

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

IMPLA-MED TITANIUM, IMPLANT DEVICES

FDA 510(k)

FDA Class 2 ·Dental

INTELEPACS, MODEL VERSION 3.X.X

FDA 510(k)

FDA Class 2 ·Radiology

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

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

2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+

FDA 510(k)

FDA Class 2 ·Radiology

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

FDA classification

FDA Class 2 ·Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Infant Supine Sleep System

FDA classification

FDA Class 2 ·Infant Supine Sleep System

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell