Andorate Universal Endoscope Tip Guard

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOBOOT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIVER TAMPONADE BALLOON

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

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCOPEJOCKEY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CamAPS FX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES