HI-NEK TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138

FDA 510(k)

FDA Class 2 ·Dental

D-CARIE, MODEL N121-M1

FDA 510(k)

FDA Class 2 ·Dental

ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ONTEX AND OTHER PROPRIETARY NAMES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CHRYSALIS

FDA 510(k)

FDA Class 2 ·Radiology

Flexitouch System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

INTRAUTERINE CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STOPCOCK

FDA 510(k)

FDA Class 2 ·General Hospital

SHIELDED TROCAR (OBTURATOR)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAPAROSCOPIC SURGICAL INSTRUMENT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology