FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC

FDA 510(k)

FDA Class 2 ·Ophthalmic

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ONCE-A-DAY BOWIE AND DICK TEST PACK.

FDA 510(k)

FDA Class 2 ·General Hospital

SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Dexcom G7 15 Day Continuous Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

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