AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Medevac Use Oxygen Generator

FDA classification

FDA Class 2 ·Medevac Use Oxygen Generator

LASEGUIDE CAT # CLF-600D & CLF-1000D

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DSC/ALF SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANCE LASER FLOWMETER, ALF 21

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·INSTRUMENTARIUM ULF MR IMAGING SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·INSTRUMENTARIUM ULF MR IMAGING SYSTEM

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

OMNIDOS

FDA 510(k)

FDA Class 2 ·Radiology

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLIRPATH EXCIMER LASER CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

FDA 510(k)

FDA Class 2 ·Hematology

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

FDA 510(k)

FDA Class 2 ·Hematology

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

FDA 510(k)

FDA Class 2 ·Hematology

Leksell Gamma Knife Icon

FDA 510(k)

FDA Class 2 ·Radiology

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

FDA 510(k)

FDA Class 2 ·Radiology

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

FDA 510(k)

FDA Class 2 ·Hematology

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

FDA 510(k)

FDA Class 2 ·Hematology

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

FDA 510(k)

FDA Class 2 ·Cardiovascular