QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash HMGCR Reagents

FDA 510(k)

FDA Class 2 ·Immunology

KATANA Zirconia Block

FDA 510(k)

FDA Class 2 ·Dental

TS-BONE HIP TOOL

FDA 510(k)

FDA Class 2 ·Orthopedic

EM PROBE, EM PAD

FDA 510(k)

FDA Class 2 ·Physical Medicine

BALLOON FOR ULTRASONIC ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Radiology

MEDCARE REGIONAL ANETHESIA KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

NUVASIVE CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STAODYN MAX PRESET, MODEL 4470

FDA 510(k)

FDA Class 2 ·Neurology

HYPERLUX 30 IMAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Borvo EVAC System (Ergo); Borvo EVAC System (Classic)

FDA 510(k)

FDA Class 2 ·Neurology

AURAVENEER CEMENT

FDA 510(k)

FDA Class 2 ·Dental

Auto 3D Bladder Volume Tool

FDA 510(k)

FDA Class 2 ·Radiology

BrainInsight

FDA 510(k)

FDA Class 2 ·Radiology

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

FDA 510(k)

FDA Class 2 ·Immunology

Pursuant Health Kiosk (G1.D5)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEREGRINE WIDE ANGLE LIGHT PIPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUANTA LITE GLIADIN IGA II

FDA 510(k)

FDA Class 2 ·Immunology

HIFLO FILTERED INSUFFLATION TUBING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology