SMARTVALVE

FDA 510(k)

FDA Class 2 ·General Hospital

HR(TM) NEEDLE AND SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACU-MED RED MISER HEMOTHORAX BLOOD COLL.

FDA 510(k)

FDA Class 2 ·Anesthesiology

Acu-sInQ Complete Endoscope Cleaning Aid System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Image1 S CCU, Image1 S 4U Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CONTACT LENSES

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 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery