Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

Endoscopic Guidewire, Gastroenterology-Urology

FDA classification

FDA Class 2 ·Endoscopic Guidewire, Gastroenterology-Urology

Endoscopic Injection Needle, Gastroenterology-Urology

FDA classification

FDA Class 2 ·Endoscopic Injection Needle, Gastroenterology-Urology

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

FDA 510(k)

FDA Class 2 ·Ophthalmic

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYSTOGLIDE DILATING INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UROLOGICAL GUIDWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

O'NEIL URINARY CATHETER INTRODUCER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FOLEY CATHETER TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URINARY CARE SUPPLIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WIJAY EZ-VOID EXTERNAL CATHETER VALVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNIVERSAL SWIVEL PATCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUARDIAN URETHRAL SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLOSED FOLEY CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TECNOL CATHETER LEG STRAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology