Intraocular Lens

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS)System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

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

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ANESTHESIA CONDUCTION NEEDLES

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Radiology

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

SD-100 SKYEAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·Neurology

Med-link Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

SUPER SOOTHER

FDA 510(k)

FDA Class 2 ·General Hospital

PADSCAN HD SERIES BLADDER SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES