Vitrea View

FDA 510(k)

FDA Class 2 ·Radiology

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GuideMia Ortho+

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDEMIA

FDA 510(k)

FDA Class 2 ·Radiology

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ureterorenoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Flexible Video-Choledo-Cysto-Ureteroscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Third Eye Panoramic Auxiliary Endoscopy System - Resposable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Multi Modality Viewer

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

TITANIUM PEG SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic