Prodiva 1.5T CX and Prodiva 1.5T CS R5.4

FDA 510(k)

FDA Class 2 ·Radiology

FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

Hyper Insight - ICH

FDA 510(k)

FDA Class 2 ·Radiology

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

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHADEBACT MONOCLONAL GC TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

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