61 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·WAVSTAT OPTICAL BIOPSY SYSTEM
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·OPTICAL BIOPSY(TM) SYSTEM
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·WAVSTAT OPTICAL BIOPSY SYSTEM
FIRST MEDIC MODE 610
FDA 510(k)
FDA Class 3
·Cardiovascular
HEARTSTART 2000
FDA 510(k)
FDA Class 3
·Cardiovascular
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·Guardian Sensor 3
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·Guardian Sensor 3
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Guardian Sensor 3
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve EnVeo R Loading System, Medtronic CoreValve EnVeo Pro Loading System, Medtronic Evolut Pro+ Loa
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH