Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

OCU-GUARD AND OCU-GUARD SUPPLE

FDA 510(k)

FDA Class 2 ·Ophthalmic

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology

DNA/RNA Shield Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-38 (POLYMACON)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORAGENE DX OGD-500.001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OCU-FILM TIP COVER

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENDLESSFIBER REUSABLE SURGICAL LASER FIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WiScope Digital Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: OCU-FILM TIP COVER

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Scope ProTech

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology