MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

PEACH 2, PEACH 2 Duo, PEACH 2 go

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MATRICEL DENTAL BARRIER MEMBRANE

FDA 510(k)

FDA Class 2 ·Dental

BonOs® Inject Bone Cement; NEO Pedicle Screw System™

FDA 510(k)

FDA Class 2 ·Orthopedic

NEO DENTA ZIRCONIA

FDA 510(k)

FDA Class 2 ·Dental

ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cranial COVER

FDA 510(k)

FDA Class 2 ·Neurology

NEO Pedicle Screw System™

FDA 510(k)

FDA Class 2 ·Orthopedic

NEO Pedicle Screw System™

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERN FIX Sternal Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

BonOs Inject Bone Cement; NEO Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Stern Fix Sternal Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

SELECTIVA GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCUPUNCTURE ACCESS WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neo Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology