34 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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MEDI CAL HealthCare GmbH
Manufacturer
🇩🇪 Germany·3 Basic UDI-DIs·3 Devices
BIACLASSICTABS
Device
EU MDD
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Eu Md Class 1
·MEDI CAL HealthCare GmbH·On the market
BIAPHASERTABS
Device
EU MDD
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Eu Md Class 1
·MEDI CAL HealthCare GmbH·On the market
BIACORPUS RX 4004M
Device
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·On the market
BIACLASSICTABS
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·1 device
BIAPHASERTABS
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·1 device
BIACORPUS RX 4004M
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·1 device
CAL
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECO Medical Instruments, Production + Trading GmbH·1 device
CAL
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·TECO Medical Instruments, Production + Trading GmbH·1 device
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC
FDA 510(k)
FDA Class 2
·Immunology
ACL GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices
OR-MD® 32 4k
Device
EU MDR
·
Eu Md Class 1
·ACL GmbH·On the market·32 countries
OR-MD® 27 4k
Device
EU MDR
·
Eu Md Class 1
·ACL GmbH·On the market·32 countries
OR-MD® 27 4k
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ACL GmbH·1 device
OR-MD® 32 4k
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ACL GmbH·1 device
Allergen Discs Aal
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
Organical CAD/CAM GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·March 19, 2014
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
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·October 11, 2017