14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
FDA 510(k)
FDA Class 2
·Immunology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127307·Apex Revision Knee System-Revision Femur Box Cu...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821820·Laryngeal Mirror #8
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690194958·Apex Revision Knee System-Revision Femur Box Cu...
MCOMPASS ANORECTAL MANOMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEFENDO Y-OPSY IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET
FDA Adverse Event
Injury
·COOK INC·Product code KNT·November 10, 2021
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 26, 2013
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 11, 2014
LINOX SMART SD 75/18
FDA Adverse Event
Malfunction
·BIOTRONIK, SE & CO KG·Product code LWS·June 29, 2011
ALINITY M SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code OOI·November 19, 2025
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019