1,254 results
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38ms
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Sources: EU EUDAMED, US FDA
REAL RESPIRATORY BACTERIAL PANEL 2 (B. pertussis, B. parapertussis, B. holmesii) (Code/código: 5.182.XXX.88.ZZZ)
Device
EU IVDR
·
Eu Ivd Class B
·OPERON, S.A.·On the market·1 country
Fluid, Hysteroscopy
FDA Pre-Market Approval
FDA Class 3
·HYSKON (32% DEXTRAN 70)
IP85092: Sterile, Single Use, CONVERTEERBAK OOZ
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HASA OPTIX·1 device
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW
IP85095: Sterile, Single Use, CHALAZION SET OOZ
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HASA OPTIX·1 device
IP85092 x10: Sterile, Single Use, CONVERTEERBAK OOZ
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HASA OPTIX·1 device
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
FDA 510(k)
FDA Class 2
·General Hospital
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
FDA 510(k)
FDA Class 2
·General Hospital
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASCULAR SOLUTION DUETT SEALING DEVICE
IP85095 x10: Sterile, Single Use, CHALAZION SET OOZ
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·HASA OPTIX·1 device
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)
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, CP, and CP 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, and Impella LD Systems
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