CORE-INJECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Retraction, CWM-910T, APOLEX Tite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Eclipse Kiss Zirconia

FDA 510(k)

FDA Class 2 ·Dental

PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION

FDA 510(k)

FDA Class 2 ·Radiology

Estar-ZE

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED LONG KING COBRA 30 & 40 PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) ACE,LONG,EXPR. HYPO-SEAL(TM) ACCESSORY

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED ACE(TM) & LONG ACE(TM) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

FD TENS 2050 OR SLIDE TENS MODEL FD2050

FDA 510(k)

FDA Class 2 ·Neurology

AquaPulse Auxiliary Water Connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

FDA 510(k)

FDA Class 2 ·Neurology

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Transcutaneous Electrical Nerve Stimulator (9029SCM)

FDA 510(k)

FDA Class 2 ·Neurology

Master-Frank N95 Particulate Respirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANDORATE® Valve Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AquaPulse Irrigation Tubing

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology