On-Body Injector

FDA classification

FDA Class 2 ·On-Body Injector

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

ALTHIN MEDICAL AB ALTRACART II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMNIDOS

FDA 510(k)

FDA Class 2 ·Radiology

PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITAFLON PLUS/VASCULON

FDA 510(k)

FDA Class 2 ·General Hospital

CLIRPATH EXCIMER LASER CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls

FDA 510(k)

FDA Class 2 ·Immunology

ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat

FDA 510(k)

FDA Class 2 ·Immunology

PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIGRAN PERIBRUSH

FDA 510(k)

FDA Class 2 ·Dental

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

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut

FDA 510(k)

FDA Class 2 ·Immunology

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX

FDA 510(k)

FDA Class 2 ·Orthopedic