WIELISA PR-3 ANCA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-PR3 (C-ANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA

FDA 510(k)

FDA Class 2 ·Immunology

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMAGYN LAPAROSCOPIC INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN UROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMAGYN FALLOPOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMPOWER EXTERNAL VACUUM SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

IMAGYN MICROLAP(TM) LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN HYSTEROSCOPE SHEATHS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN MICROLAP INTRODUCER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMAGYN HYSTEROSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSPAN INSEMINATION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology