151 results · 35ms · Sources: EU EUDAMED, US FDA

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON MODELS 911A AND 913A, TECNIS MODELS Z9000 AND Z9001

FDA Pre-Market Approval
MediBeacon® Transdermal GFR Measurement System (TGFR)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX-XP/GFX2 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM