GDT-1000 System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HLA-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C

FDA 510(k)

FDA Class 2 ·Ophthalmic

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SRH-678 VACCUUM TUBING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRF CHARCOAL CANISTER REPLACEMENT FILTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·GUT

CDC ZIRCONIA BLANKS

FDA 510(k)

FDA Class 2 ·Dental

MIRAGE BOND

FDA 510(k)

FDA Class 2 ·Dental

ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADT PERCUTANEOUS NON-DISP. NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XENX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology