NEXUS INJECTION SITE (NIS), MODEL NIS-1

FDA 510(k)

FDA Class 2 ·General Hospital

FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VAKU-8 BLOOD COLLECTION NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

Senhance Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QScout Lab; QScout RLD

FDA 510(k)

FDA Class 2 ·Hematology

PLATELIN(R) EXCEL L

FDA 510(k)

FDA Class 2 ·Hematology

UTC 3mL Medication Cartridge

FDA 510(k)

FDA Class 2 ·General Hospital

DIRECT PERORAL CHOLANGIOSCOPY BALLOON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PeraServer and PeraTrend

FDA 510(k)

FDA Class 2 ·Cardiovascular

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

FLUID REISISTANT EYESHIELD MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST

FDA 510(k)

FDA Class 2 ·Hematology

PRESTIGE 24I; BIOLIS 24I; MGC 240

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE

FDA 510(k)

FDA Class 2 ·Radiology

EnFocus 2300, EnFocus 4400

FDA 510(k)

FDA Class 2 ·Ophthalmic

LipiFlow Thermal Pulsation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZ-IO Intraosseous Vascular Access System

FDA 510(k)

FDA Class 2 ·General Hospital

X Sensor (Model: IOS-A15IF, HDI-15DGF)

FDA 510(k)

FDA Class 2 ·Dental

RUBENOSTIKA IGG MICROELISA SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology