Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTVIEW SPHERICAL & TORIC CONTACT LENS

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·CILCO ND:YAG LASER

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

FDA 510(k)

FDA Class 2 ·Cardiovascular

C50 and C80 Multi-parameter Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ZQUIET MOUTHPIECE

FDA 510(k)

FDA Class 2 ·Dental

Para-Fix External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

HydroPearl Microspheres, HydroPearl Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER

FDA 510(k)

FDA Class 2 ·Ophthalmic

NASOPHARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Atellica® CH Creatinine_3 (Crea3)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAYFIELD ADULT DISPOSABLE SKULL PIN

FDA 510(k)

FDA Class 2 ·Neurology

CONCEPTUS UTERINE CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARSTASIS DILATOR ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

FDA 510(k)

FDA Class 2 ·Orthopedic

AURAFLEX B2-MICROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FREERIDER FR1, models FR1-13, FR1-15, FR1-17

FDA 510(k)

FDA Class 2 ·Physical Medicine