24 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Insignis Subcutaneous Needle Sets
FDA 510(k)
FDA Class 2
·General Hospital
APS INPUT OUTPUT MODULE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JQP·July 4, 2012
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM
36M - Navajo Tribal Utility Authority
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority
ML EYE SPEAR, MODEL ML 27 ES
FDA 510(k)
FDA Class 2
·Ophthalmic
INCU I
FDA 510(k)
FDA Class 2
·General Hospital
IMED
FDA Adverse Event
Injury
·IMED CORPORATION·Product code FRN·June 16, 2006
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 11, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 27, 2014
UNKNOWN PAINPUMP PRODUCT
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS KALAMAZOO·Product code FRN·July 26, 2011
TYVASO INHALATION SYSTEM
FDA Adverse Event
Malfunction
·UT GMBH·Product code CAF·July 1, 2013
OPTICROSS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 6, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·July 27, 2023
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·July 25, 2022
TRIMA ACCEL
FDA Adverse Event
Injury
·TERUMO BCT·Product code GKT·November 11, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·July 27, 2023
ECHELON 60
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 22, 2023
CONCERTO
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·December 7, 2022
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·December 15, 2023