60 results
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34ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113707·CYSTOTOME FORMED 23GA
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Z-TOUCH
FDA 510(k)
FDA Class 2
·Neurology
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Enforcement
Class II
·Terminated·Anodyne Surgical·June 23, 2021
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 25, 2022
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 4, 2022
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 4, 2022
MANTIS CANNULATED MODULAR TAP 5.5MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code HWX·October 14, 2008
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2013
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·June 1, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·October 5, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·October 31, 2022
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 20, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·September 24, 2022