27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lung Analysis Software
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Oticon A/S·05707131288189·H330V2, DESIGNRITE 10 WL THP AGXO
ProLift
FDA UDI
Life Spine, Inc.·00190837117528·
Pro Lift Instruments
FDA UDI
Life Spine, Inc.·00190837031145·
Crosslink Bonding Adhesives
FDA UDI
TP ORTHODONTICS INC·00192029000137·CROSSLINK SMALL PATIENT CAPLET, NATURAL COLO...
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00812171029939·ETHOS PRO LABRAL ANCHOR, TITANIUM, 2.9mm x 10mm...
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK REVISION HYBRID LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962103739·ETHOS PRO LABRAL ANCHOR, TITANIUM, 2.9mm x 10mm...
PROPHECY INFINITY
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 7, 2013
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·June 7, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·July 1, 2008
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 8, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 19, 2023
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 28, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 15, 2025
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 2, 2022
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 22, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 11, 2024