4.0MM SIMPLER ONE THREADED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

ONE INCISION BI-POLAR ELECTRO. FORCEPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FRESHLOOK ONE-DAY COLOR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUIKPAC II ONE STEP COCAINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LION SE ONE STEP ORTHODONTIC ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental

Aquilion ONE (TSX-305A/3) V7.3

FDA 510(k)

FDA Class 2 ·Radiology

ONE-STEP DOUBLE-CHEK PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Halo One Thin-Walled Guiding Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

MDI MII ONE-PIECE IMPLANT, 2.9MM

FDA 510(k)

FDA Class 2 ·Dental

AFFIRM ONE-STEP HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aquilion ONE (TSX-306A/3) V10.0

FDA 510(k)

FDA Class 2 ·Radiology

PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALL-IN-ONE TWO CHAMBER CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

Aquilion ONE (TSX-308A/3) V1.5

FDA 510(k)

FDA Class 2 ·Radiology

Rampart One Lumbar Interbody Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

TSolution One w/ACG+ Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

CVIS ULTRA-SCAN ONE IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CVIS ULTRA-SCAN ONE IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Radiology

P-1 (PREIMPLANTATION STAGE ONE) MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology