23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PASCAL STREAMLINE 577 (WITH ACCESSORIES)
FDA 510(k)
FDA Class 2
·Ophthalmic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310111108110·
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODALIXX
FDA 510(k)
FDA Class 2
·Radiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 9, 2023
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022
HEARTMATE II LVAD
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·May 9, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·August 30, 2022
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·April 19, 2021
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·December 11, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·November 30, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·December 3, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·November 27, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·September 17, 2020
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·December 7, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·May 29, 2019
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·March 3, 2020
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025