LASER IRAS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IRAS PERIMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPULSE HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iPulse Smooth Skin Gold Hair Removal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iPulse SmoothSkin Gold Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Venus Silk.expert

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iPulse SmoothSkin BARE Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CODA CX1 MOTION ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Pump In Style Advanced, Advanced Personal Double Breastpump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOL-GUARD Safety Pull Button Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alivio Ventricular Catheter and Flusher System (Alivio System)

FDA 510(k)

FDA Class 2 ·Neurology

TUTOPATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery