10 results
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45ms
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Sources: EU EUDAMED, US FDA
GFA PRODUCTION INC
FDA registration
GFA PRODUCTION INC·2 products·🇺🇸 United States
PULSE GEN MODEL 106
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·September 18, 2024
Wellkang Ltd
Authorized representative
259 Manufacturers·3500 Devices
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·July 27, 2007
DAVINCI XI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 25, 2026
Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc·December 21, 2016
Normedan S.L.
Importer
🇪🇸 Spain·2 Manufacturers
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices