FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus

FDA 510(k)

FDA Class 2 ·Ophthalmic

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NIC 1800 NEEDLE DISPOSAL SYSTEM

HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

FDA 510(k)

FDA Class 2 ·Dental

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054

FDA 510(k)

FDA Class 2 ·Cardiovascular

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

NEURON DELIVERY CATHETER 070

FDA 510(k)

FDA Class 2 ·Cardiovascular

COATEST PROTEIN C

FDA 510(k)

FDA Class 2 ·Hematology

Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW

FDA 510(k)

FDA Class 2 ·Dental

OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

Penumbra System ACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA COIL SYSTEM/PENUMBRA COIL 400

FDA 510(k)

FDA Class 2 ·Neurology

PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4

FDA 510(k)

FDA Class 2 ·Dental

DIATHRON(R) DIATHERMY UNIT

FDA 510(k)

FDA Class 2 ·Ophthalmic