1,386 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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OrthoXel DAC
Manufacturer
🇮🇪 Ireland·776 Basic UDI-DIs·786 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
AventaMed DAC
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.
Mainstay Medical Limited
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 13, 2019
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 13, 2019
Best Putra Gloves (Global) Limited
Authorized representative
🇮🇪 Ireland·1 Manufacturer
Apex Antegrade Femoral Endcap 15mm length
Device
EU MDD
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Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Antegrade Femoral Endcap 10mm Length
Device
EU MDD
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Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Antegrade Femoral Endcap 5mm Length
Device
EU MDD
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Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Antegrade Femoral Endcap 0mm Length
Device
EU MDD
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Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 460mm
Device
EU MDD
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Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 440mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 420mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 400mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 380mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 360mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 340mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 320mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 300mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country
Apex Femoral Nail PF Right Ø 10.0 x 280mm
Device
EU MDD
·
Eu Md Class 2b
·OrthoXel DAC·On the market·1 country