317 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CAPSURE SP NOVUS
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·TENDRIL STS LEAD MODEL 2088TC
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL FLEX ABLATION CATHETER
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·AccelStim
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CAPSURE Z MODELS 5034/5534/5033 PACING LEADS
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·ORCHESTRA PROGRAMMER
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ISOFLEX S PERMANENT PACING LEAD MODELS