MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ELECSYS FSH CALSET II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOPYLEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 285CM INFUSION PUMP, MODIFICATION

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOPATH* DISPOSABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMET CAPNOGRAPH MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

V-PRIMER

FDA 510(k)

FDA Class 2 ·Dental

DYRACT(TM) MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DAN KERRISON RONGEURS, MODELS K1 + BILLY 1

FDA 510(k)

FDA Class 2 ·Neurology

OSTEON BONE MINERAL ANALYZER

FDA 510(k)

FDA Class 2 ·Radiology

COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COHERENT XA-40 CO2 SURGICAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)

FDA 510(k)

FDA Class 2 ·Orthopedic

TITAN GEL-PC GLYCO-HEME(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS

FDA 510(k)

FDA Class 2 ·Radiology

OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology