HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.

FDA 510(k)

FDA Class 2 ·Dental

P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR

FDA 510(k)

FDA Class 2 ·Neurology

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

FDA 510(k)

FDA Class 2 ·General Hospital

Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LumenaTM Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

INFINITI SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic