63 results · 22ms · Sources: EU EUDAMED, US FDA

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ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000

FDA 510(k)
FDA Class 2 ·Neurology

myQA iON; Article Number: MQ10-000;

FDA Enforcement
Class II ·Ongoing·IBA Dosimetry GmbH·May 7, 2025

ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

FDA Enforcement
Class II ·Ongoing·Carl Zeiss Meditec AG·May 4, 2022

IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

FDA Enforcement
Class II ·Terminated·Iba Dosimetry Gmbh·January 27, 2016

ALEGRO Alginate

Device
EU MDR · Eu Md Class 1 ·Alegro Medical GmbH·On the market

4-motion® knee inlay

Device
EU MDD · Eu Md Class 3 ·ARTIQO GmbH·On the market·1 country

CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000

FDA 510(k)
FDA Class 1 ·Radiology

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

ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,

FDA 510(k)
FDA Class 2 ·Orthopedic

Gehwagen

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·2 devices

Gehwagen

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·3 devices

Lauflernhilfen

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·2 devices

Lauflernhilfen

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·2 devices

Rollatoren

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·1 device

Rollatoren

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·6 devices

Gehgestelle

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·6 devices

Griffe und Handläufe

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·1 device

Duschhocker

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·3 devices

Duschhocker

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·1 device

Multifunktions-Pflegerollstühle

Basic UDI-DI
EU MDR · Eu Md Class 1 ·REBOTEC Rehabilitationsmittel GmbH·5 devices