2,346 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP PROCESSORS
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR CPSA ASSAY
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·Bulkamid Urethral Bulking System
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS®) Liver
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·NUVISC
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Microspheres Radionuclide
FDA Pre-Market Approval
FDA Class 3
·TheraSphere
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
FDA Pre-Market Approval
FDA Class 3
·RESQCPR SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·SCORPION & SCORPION M ABLATION CATHETERS
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP IMAGING SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Stent, Iliac Vein
FDA Pre-Market Approval
FDA Class 3
·VICI VENOUS STENT System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ORBERA INTRAGASTRIC BALLOON SYSTEM
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ADIANA PERMANMENT CONTRACEPTION SYSTEM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation (SNM) System for Urinary Control
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)