Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

LC Bead LUMI

FDA 510(k)

FDA Class 2 ·Cardiovascular

LC Bead LUMI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bead Block

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPEED 808 DIODE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GALAXY CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER

FDA 510(k)

FDA Class 2 ·Radiology

SPACE(TM) 7500

FDA 510(k)

FDA Class 2 ·Physical Medicine

SNOR LOCK

FDA 510(k)

FDA Class 2 ·Dental

IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Orthopedic

NYLUS PICC

FDA 510(k)

FDA Class 2 ·General Hospital

TYMPANOSTOMY VENTILATION TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955

FDA 510(k)

FDA Class 2 ·Neurology

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode laser hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COLLAWOUND HYDROGEL

FDA 510(k)

FDA Unclassified ·Unknown

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIODE LASER FOR HIAR REMOVAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE TRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology