AUTOMATED DISPOSABLE KERATOME (ADK)

FDA 510(k)

FDA Class 1 ·Ophthalmic

LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD K-4000 MICROKERATOME SYSTEM

FDA 510(k)

FDA Class 1 ·Ophthalmic

CERAMAX

FDA 510(k)

FDA Class 2 ·Dental

REWINNER ENT H.K. BRANCH NON-PRESCRIPTION SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Kawasumi Laboratories Blood Drawing Kit (BDK) System

FDA 510(k)

FDA Class 2 ·Hematology

TCL3 Motion Tracking System

FDA 510(k)

FDA Class 2 ·Radiology

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

V-CATH BREAKAWAY NEEDLE INTRODUCER

FDA 510(k)

FDA Class 2 ·General Hospital

ENTERO-TEST HP, MODEL #102-01

FDA 510(k)

FDA Class 1 ·Microbiology

PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15

FDA 510(k)

FDA Class 2 ·Anesthesiology

HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DENU Composite Resin, DENU Flow Resin

FDA 510(k)

FDA Class 2 ·Dental

HDC SPIDER SCREW

FDA 510(k)

FDA Class 2 ·Dental

SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S

FDA 510(k)

FDA Class 2 ·General Hospital

V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)

FDA 510(k)

FDA Class 2 ·General Hospital

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

FDA 510(k)

FDA Class 2 ·Dental

V-CATH

FDA 510(k)

FDA Class 2 ·General Hospital

CHEMO-CATH INTRAPERITONEAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology