620 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·ADEPT Adhesion Reduction Solution
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT®.TB Test
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, CP, and CP with SmartAssist
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT TB TEST
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, and Impella LD Systems
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT .TB TEST
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus® UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella CP Ventricular Support System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst
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 LD, Impella 5.5 with Smart Assist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella Ventricular Support Systems
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella CP with SmartAssist, Impella 5.5 with SmartAssist
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/LD, Impella 5.5 with SmartAssist
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/LD, Impella 5.5 with SmartAssist
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 Systems