16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GR Splint Resin System
FDA 510(k)
FDA Unclassified
·Unknown
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK114151·DD tempMED are pre-colored dental milling blank...
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113461·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185626·AccuFit™ Molar Band UR7 - 41.5
3D Printed Interbody Systems
FDA UDI
Seaspine Orthopedics Corporation·10889981303945·2-Hole No-Profile Interbody, 35mm x 27mm x 14mm...
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981309831·Trial Rasp, 35mm x 27mm x 14mm, 15 Deg
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981215392·No-Profile Interbody, 35mm x 27mm x 14mm, 15 Deg
MOLLRING MULTITASC
FDA 510(k)
FDA Class 2
·Cardiovascular
ALPCO MILENIA ANTI-TG EIA
FDA 510(k)
FDA Class 2
·Immunology
2246640-1999-00003
FDA Adverse Event
Other
·December 15, 1999
GOLD RELOAD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 15, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD) -3006260740·Product code FPA·December 1, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021