45 results · 28ms · Sources: EU EUDAMED, US FDA

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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