1,104 results
·
32ms
·
Sources: EU EUDAMED, US FDA
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
FDA 510(k)
FDA Class 1
·Ophthalmic
LENSES, EYEGLASS, SAFETY
FDA 510(k)
FDA Class 1
·Ophthalmic
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
TECHNA VISION CASTING RESIN
FDA 510(k)
FDA Class 1
·Ophthalmic
MULTIPLE LENS, SPECTACLES CUSTOM
FDA 510(k)
FDA Class 1
·Ophthalmic
Sofia 2
FDA registration
Ortho-Clinical Diagnostics, Inc.·2 products·🇺🇸 United States
Sofia 2
FDA registration
Ortho-Clinical Diagnostics, Inc.·2 products·🇺🇸 United States
Sofia 2
FDA registration
QUIDEL CORP.·2 products·🇺🇸 United States
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC pharmDx
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2