Mediracer NCS

FDA 510(k)

FDA Class 2 ·Neurology

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTOMED SMARTSCOPE, MODEL M3-1 EY1

FDA 510(k)

FDA Class 2 ·Ophthalmic

Optomed Smartscope M5 with Optomed Smartscope FA

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

FDA 510(k)

FDA Class 2 ·Ophthalmic

Harmony Referral System

FDA 510(k)

FDA Class 2 ·Radiology

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

FDA 510(k)

FDA Class 2 ·Immunology

HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

REPROCESSED HOT BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

FDA 510(k)

FDA Class 2 ·Dental

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES