496 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension TPSA Flex reagent cartridge
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension Vista TPSA Flex reagent cartridge (K6451)
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ST AIA-PACK PA
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Elecsys free PSA
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·CIBA CORNING ACS PSA IMMUNOASSAY
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·CIBA CORNING ACS PSA IMMUNOASSAY
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
FDA 510(k)
FDA Class 2
·Radiology
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
FDA 510(k)
FDA Class 2
·Orthopedic
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
FDA 510(k)
FDA Class 2
·Radiology
IH Implant System
FDA 510(k)
FDA Class 2
·Dental
TISSUE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·OPTI-ONE(R) MULTI-PURPOSE SOLUTION
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV II IMMUNOASSAY.
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·OPTI-ZYME ENZYMATIC CLEANER