Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AirStrip ONE Web Client with Alarm Communication Management (ACM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

FDA 510(k)

FDA Class 2 ·Radiology

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

FDA 510(k)

FDA Class 2 ·Dental

FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9

FDA 510(k)

FDA Class 2 ·Dental

ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

FDA 510(k)

FDA Class 2 ·Radiology

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DMRC Self-Cure Bracket Adhesive One Step and Primer

FDA 510(k)

FDA Class 2 ·Dental

ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology