2,258 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Urinary Control System with and without InhibiZone
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Intera 3000 Hepatic Artery Infusion Pump
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP(R) PROCESSOR, MODEL TP 2000
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBC TOTAL ASSAY
Stent, Urethral, Prostatic, Semi-Permanent
FDA Pre-Market Approval
FDA Class 3
·THE SPANNER TEMPORARY PROSTATIC STENT
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC-ONE (HYLAN G-F 20)
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID IMPLANTABLE INFUSION PUMP
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC and SYNVISC ONE