Aingeal Activity System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartKey® Rhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

zensor system

FDA 510(k)

FDA Class 2 ·Cardiovascular

B-Secur HeartKey Software Library

FDA 510(k)

FDA Class 2 ·Cardiovascular

Probe Covers (YF-001, YF-002)

FDA 510(k)

FDA Class 2 ·General Hospital

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)

FDA 510(k)

FDA Class 2 ·Cardiovascular

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HTx Disposable Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dental Porcelain Powder

FDA 510(k)

FDA Class 2 ·Dental

TENS & PMS Unit

FDA 510(k)

FDA Class 2 ·Neurology

Air Compression Leg Massager (K-705)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Air Smart Extra Spirometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pre-Sintered Zirconia Coloring Liquid

FDA 510(k)

FDA Class 2 ·Dental

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery