MDA SIMPLASTIN HTF

FDA 510(k)

FDA Class 2 ·Hematology

MALE NATURAL RUBBER LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SARSTEDT NEEDLE PROTECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

HEM-O-LOK MODEL NUMBERS 523900, 523970

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISP Safety Huber Needle Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

EVOL Spinal Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

COAG-A-MATE - RA4

FDA 510(k)

FDA Class 2 ·Hematology

ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RUSCH POLYFLEX STENT KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT/PB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

DEKA TAC DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ISOSTATION ANKLE/SUBTALAR MACHINE A-100

FDA 510(k)

FDA Class 2 ·Physical Medicine

ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

SPINALATOR JS-1100 TRACTION UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

LifeFlow Blood System

FDA 510(k)

FDA Class 2 ·General Hospital

BEDSIDE BUTLER

FDA 510(k)

FDA Class 2 ·Physical Medicine

FLIGHT 60 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology