NuVasive® ACP System

FDA 510(k)

FDA Class 2 ·Orthopedic

URIS OMNI System

FDA 510(k)

FDA Class 2 ·Dental

ABMD Software

FDA 510(k)

FDA Class 2 ·Radiology

THERMAGE THERMACOOL COUPLING FLUID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMAGE FUSION AND REVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CEDIA (R) VITAMIN B12/FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SILKAM NONABSORBABLE SILK SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IRIDERM, MODEL APEX 800

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACON ONE STEP HOME PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SyncVision System

FDA 510(k)

FDA Class 2 ·Radiology

PROSPECT GIARDIA

FDA 510(k)

FDA Class 2 ·Microbiology

PERCUSSIVENEB, MODEL PN-2001

FDA 510(k)

FDA Class 2 ·Anesthesiology

BAUMAN CPR/RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COPAL DIGITAL SPHYGMOMANOMETER UA-535

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAICHEM(TM) CREATINE KINASE-MB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STACKHOUSE LENS HOOD, MODEL SA-700/F

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular