Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

FDA 510(k)

FDA Class 2 ·Radiology

I-LIPO SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JO H2O Jelly Original Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GEO Extremity and Ankle Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

FDA 510(k)

FDA Class 2 ·Immunology

HE4 EIA, MODEL: 404-10 US

FDA 510(k)

FDA Class 2 ·Immunology

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

FDA 510(k)

FDA Class 2 ·Immunology

GEO 1st MTP Joint Arthrodesis Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NLITE SYSTEM,MODEL A00-1051

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELECTRODE, FLEXIBLE SUCTION COAGULATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0

FDA 510(k)

FDA Class 2 ·Anesthesiology

JO for Him H2O Gel Original Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Gun Oil, Pink, Gun Oil H2O, Pink Water

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)

FDA 510(k)

FDA Class 2 ·Ophthalmic