45 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX UF-50
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX(TM) F-820, 520
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX SE/RAM-1
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX UF-100
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX CA-1000/SYSMEX CA-5000
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX K-4500
FDA 510(k)
FDA Class 2
·Hematology
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SELENIA DIMENSIONS (2D) FFDM SYSTEM
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SIEMENS MAMMOMAT NOVATION FFDM SYSTEM
PSA ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
VENTANA CEA PRIMARY ANTIBODY
FDA 510(k)
FDA Class 2
·Immunology
PAP ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
DYNABITE HYSTEROSCOPIC FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DYNABITE LAPAROSCOPIC FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DYNABITE HOT GI BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SENOGRAPHE DS & 2000D FFDM SYSTEM
COOLAN 300
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM