KDF-2.3

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ASPIRETTE ENDOCERVICAL ASPIRATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CERVEX-BRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HUI MINI-FLEX

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Phenom 27 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Suture Wing

FDA 510(k)

FDA Class 2 ·Orthopedic

EXCELSIOR 1018 AND SL-10 MICROCATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOMETRIAL PIPELLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Kosmos

FDA 510(k)

FDA Class 2 ·Radiology

PROBE SHEATH FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Radiology

BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PSG(TM) EDM(TM) INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Athena GTX Device Management Suite (ADMS) Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

Duet External Drainage and Monitoring System (EDMS)

FDA 510(k)

FDA Class 2 ·Neurology