13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive NuvaLine
FDA 510(k)
FDA Class 2
·Radiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741924350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674192435060·
BEYONDIMAGE WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
VERSEO AIR PRESSURE MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·November 4, 2004
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·Product code NPL·June 10, 2020
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
PROTECTIV PLUS-W SAFETY I.V CATHETER RADIOPAQUE 20X11/4
FDA Adverse Event
Injury
·MFG FOR SMITHS MEDICAL BY: MEDEX·Product code FOZ·October 7, 2008
ENDURON 10D 54OD X 28ID
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·June 27, 2013
LEAD MODEL 304
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 27, 2011
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018