PLS MINI

FDA 510(k)

FDA Class 2 ·General Hospital

RYUSEI

FDA 510(k)

FDA Class 2 ·General Hospital

ERYTHROCYTE TEST

FDA 510(k)

FDA Class 2 ·Hematology

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE

FDA 510(k)

FDA Class 2 ·Hematology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAXXUM AND NC MAXXUM PTCA CATHETER

QUANTA LITE ACA IGM (HRP)

FDA 510(k)

FDA Class 2 ·Immunology

DECAPINOL ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

SINCLAIR ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

HeartFocus (V.1.1.1)

FDA 510(k)

FDA Class 2 ·Radiology

Cardiac Guidance

FDA 510(k)

FDA Class 2 ·Radiology

UltraSight AI Guidance

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK & ACS FLOW TRACK 40

CAREMIBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

PASTURE, MODELS: F550, A520

FDA 510(k)

FDA Class 2 ·General Hospital