Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Ophthalmic

SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Signia Four-Bay Smart Charger (to be used with Signia Stapler)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing

FDA 510(k)

FDA Class 2 ·Orthopedic

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

POST SURGICAL KIT/POST BIOPSY KIT

FDA 510(k)

FDA Class 2 ·General Hospital

picoAMH ELISA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SNORKEL

FDA 510(k)

FDA Class 2 ·Dental

ATG/SM-OSA APPLIANCES

FDA 510(k)

FDA Class 2 ·Dental

FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

FDA 510(k)

FDA Class 2 ·Dental

ELASTOMERIC SLEEP APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental