13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KAGER TRAPDUST
FDA 510(k)VENTURE™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902989209·PLATE 9790085 ANT CERV ASSY 85MM
VENTURE™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000890254·PLATE 9790085 ANT CERV ASSY 85MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196327·AK3 PS Instruments Pan
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195016·AK3 PS Instruments Pan Insert
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
FDA 510(k)
FDA Class 2
·Cardiovascular
Journey II Unicompartmental Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
1000 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
COBAS P (701) POST ANALYTICAL UNIT
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code JJE·May 5, 2014
VERSA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·October 15, 2012
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·August 2, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024