45 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074459653·INSTRUMENT 8880049 FEELER PROBE
Arthrex®
FDA UDI
ARTHREX, INC.·00888867424746·Drill Bit, Ø1.7mm
Arthrex
FDA UDI
Provision·B504OMAR18800490·
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 1S & 1P
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
PARADYM 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·August 5, 2014
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code MRM·April 25, 2014
PARADYM 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·January 30, 2015
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBe assay and Control
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 1S & 1P
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL MUREX Anti-HBe; LIAISON XL MUREX Control Anti-HBe
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX Anti-HBe assay and Control
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe