64 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Helistat and Helitene Absorbable Collagen Hemostatic Agent
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgergy
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ISERT PY-60AD
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System