13 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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Elis Ost GmbH
Manufacturer
🇩🇪 Germany
Gründler GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY
Fiagon GmbH
Manufacturer
🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY
PAUSCH Medical GmbH
Manufacturer
🇩🇪 Germany·SGS FIMKO OY
Rhyk Technologies GmbH
Manufacturer
🇩🇪 Germany·SGS FIMKO OY
OMT GmbH & Co. KG
Importer
🇩🇪 Germany
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·October 24, 2018
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
FDA Enforcement
Class II
·Ongoing·Contract Medical International GmbH·September 17, 2025
FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·February 11, 2015
FI24/00000064
Certificate
MDR QMS·Fiagon GmbH·SGS FIMKO OY
FI23/00000052
Certificate
MDR QMS·PAUSCH Medical GmbH·SGS FIMKO OY
FI23/00000046
Certificate
MDR QMS·Rhyk Technologies GmbH·SGS FIMKO OY
FI23/00000013
Certificate
MDR QMS·Gründler GmbH·SGS FIMKO OY