10,000 results
·
111ms
·
Sources: EU EUDAMED, US FDA
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX CRT DEVICE & CARDIOMESSENGER II
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·PHILOS DR-T AND CYLOS DR-T
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 530G System
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·OVER THE WIRE DILATATION CATHETERS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME REVEL SYSTEM
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·ANIMAS VIBE SYSTEM
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·ICAD
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System, Verify® Evaluation System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW3
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Guardian Connect System
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·THINLINE II/FINELINE II STEROX PACING LEADS
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
FDA Pre-Market Approval
FDA Class 3
·ADCON -L ADHESION CONTROL IN A BARRIER GEL
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ATLAS DR/VR IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MiniMed Paradigm Real-Time Revel System