GRADILEIDEN V TEST

FDA 510(k)

FDA Class 2 ·Hematology

PEFAKIT APC-R FACTOR V LEIDEN

FDA 510(k)

FDA Class 2 ·Hematology

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Radiology

FETAL BLOOD SAMPLING KIT #1560

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COATEST(R) APC(TM) RESISTANCE

FDA 510(k)

FDA Class 2 ·Hematology

STACLOT(R) PNP TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT

FDA 510(k)

FDA Class 2 ·Hematology

CEPHALINEX ACTIVATED PTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

PLATELET EXTRACT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

PTT-LA TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

HEP-TROL

FDA 510(k)

FDA Class 2 ·Hematology

PTT-LT TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

PHOSPHOLIN ES AND CALCIUM CHLORIDE

FDA 510(k)

FDA Class 2 ·Hematology

ACTIN FS ACTIVATED PTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

AB-TROL COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

MAGNA SURGICAL PACKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGNA OBSTETRICAL PACKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGNA SURGEONS GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA 2