9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496040644·LONG, SIZE ML, MOKA, MICRO-MASSAGING LEGGINGS W...
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
FDA 510(k)
FDA Class 1
·General Hospital
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INIDA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 22, 2011
WALLSTENT RX BILIARY ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC IRELAND, LTD·Product code FGE·May 8, 2008
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018