Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER

ISOLATION GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nu-beca Transcutaneous Electrical Nerve Stimulation

FDA 510(k)

FDA Class 2 ·Neurology

CP620G LCD monitor, CP620 LCD monitor

FDA 510(k)

FDA Class 2 ·Radiology

Panpac Flexi Shelf Pessary

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

PANPAC VAGINAL DILATORS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PROASIA, MODEL L4501

FDA 510(k)

FDA Class 2 ·Physical Medicine

SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

HL148 & HL168

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROASIA, MODEL L3402

FDA 510(k)

FDA Class 2 ·Physical Medicine