15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
FDA 510(k)
FDA Class 2
·Ophthalmic
COMEN MULTI-PARAMETER PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROVERTER URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 25, 2019
INDIGO SYSTEM ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code QEW·August 7, 2023
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 3, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2014
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 20, 2011
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2024
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 22, 2019
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 4, 2025
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 13, 2025
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 20, 2025
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 5, 2017
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018