1,254 results · 38ms · 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