Spinal Anesthesia Kit

FDA classification

FDA Class 2 ·Spinal Anesthesia Kit

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME & CUTTING BALLOON ULTRA

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

Andorate Universal Endoscope Tip Guard

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOBOOT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERMA FACIAL IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

TERUMO MICRO TAPERED PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital