NIFA NON INVASIVE FLUTTER ASSEMBLY

FDA 510(k)

FDA Class 2 ·General Hospital

FINGER PULSE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO 4CIS VANE SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRUST

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: GIRAFFE AND PANDA WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

GORE REVOX THYROPLASTY IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OPTOVISION Endoscopic Light Source Unit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUIX RAPID CHOLERA STRIP TEST

FDA 510(k)

FDA Class 2 ·Microbiology

RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053

FDA 510(k)

FDA Class 2 ·Neurology

STELLAR 300

FDA 510(k)

FDA Class 2 ·Cardiovascular

BALLOON WEDGE PRESSURE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TEST ONE

FDA 510(k)

FDA Class 2 ·Physical Medicine

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BIO-INDUSTRY STIM POCHE(R)

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPIOX AF125X ARTERIAL FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEFEND FLUID RESISTANT PLEATED MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHEETAH RELIANT

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTI UNICONDULAR INTERPOSITIONAL SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

TIGECYCLINE 15UG BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology