12 results
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25ms
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Sources: EU EUDAMED, US FDA
LUBRICANT, OTRHO PERSONAL
FDA 510(k)
FDA Class 1
·General Hospital
VENTURE™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902989216·PLATE 9790087 ANT CERV ASSY 87 5MM
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761990456·Trumpf Medical/Medizin Pelvis extension long V
VENTURE™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000890261·PLATE 9790087 ANT CERV ASSY 87 5MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127291·Apex Revision Knee System-Revision Femur Size 1...
EzDent-i / E2 / Prora View
FDA 510(k)
FDA Class 2
·Radiology
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 5, 2014
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·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
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025