34 results · 29ms · Sources: EU EUDAMED, US FDA

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MEDI CAL HealthCare GmbH

Manufacturer
🇩🇪 Germany·3 Basic UDI-DIs·3 Devices

BIACLASSICTABS

Device
EU MDD · Eu Md Class 1 ·MEDI CAL HealthCare GmbH·On the market

BIAPHASERTABS

Device
EU MDD · 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 · 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