Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

REHASTIM 2, REHAMOVE 2

FDA 510(k)

FDA Class 2 ·Neurology

RehaStim 2

FDA 510(k)

FDA Class 2 ·Neurology

REHASTIM & REHAMOVE

FDA 510(k)

FDA Class 2 ·Neurology

REHASTIM 2, ERIGOPRO (FES)

FDA 510(k)

FDA Class 2 ·Neurology

CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)

FDA 510(k)

FDA Class 2 ·Orthopedic

SC1 Handheld Ultrasound Imaging system (Model: SC1)

FDA 510(k)

FDA Class 2 ·Radiology

SC1 Handheld Ultrasound Imaging System (Model: SC1)

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

TITANIUM PEG SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOCERAMIC ORBITAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FACE TANNER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUN TANNING BED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EZYPOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

FDA 510(k)

FDA Class 2 ·Ophthalmic