BACTIDROP ACRIDINE ORANGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Fluorometric, Calcium

FDA classification

FDA Class 2 ·Fluorometric, Calcium

Asnis JFX System

FDA 510(k)

FDA Class 2 ·Orthopedic

HFO SHOULDER COIL

FDA 510(k)

FDA Class 2 ·Radiology

SANICURE DISPOSABLE CURING PROBE

FDA 510(k)

FDA Class 2 ·Dental

J-FX CERCLAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

J-FX BIPOLAR HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ENA HFO COMPOSITE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ACCUSYTE 3D Fiducial Marker

FDA 510(k)

FDA Class 2 ·Radiology

GISH RELIANCE OXYGENATOR (MODEL HFO)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIGNA HFO/I MAGNETIC RESONANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

ASEPT Peritoneal Drainage System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cortera Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

JetCan® Pro Safety Huber Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Dr's Light2

FDA 510(k)

FDA Class 2 ·Dental

Fortilink with TiPlus Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

IC-WHCD100 (Inspire)

FDA 510(k)

FDA Class 2 ·Dental