87 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
FDA classification
FDA Class 3
·Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK® CR2 Defibrillator
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3