10,000 results · 78ms · Sources: EU EUDAMED, US FDA

BEHRING COAGULATION TIMER ANALYZER (BCT)

FDA 510(k)
FDA Class 2 ·Hematology

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STAR Apollo Mapping System

FDA 510(k)
FDA Class 2 ·Cardiovascular

WIRELESS MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)

FDA 510(k)
FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES

Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·STERIDYNE DYNASPRAY

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval
FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS

Bone Cement

FDA Pre-Market Approval
FDA Class 2 ·BONECEMENT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CORDIS ORION STEERABLE PTCA BALLOON CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval
FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval
FDA Class 2 ·GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS

Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE