35 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Repagyn vaginal suppositories
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111061042·SKLARCUT STEVENS TEN SCISS STR
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304222168·
NUVANT, MOBILC CARDIAC TELEMETRY
FDA 510(k)
FDA Class 2
·Cardiovascular
LBI CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 16, 2025
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·October 8, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 8, 2013
OCTRODE 60-CM LENGTH PERCUTANEOUS TRIAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 13, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 19, 2019
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 20, 2019
KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 21, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 14, 2022
KANEKA PTCA CATHETER CO-R8 (TASUKI)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 13, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·December 21, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 13, 2022
KANEKA PTCA CATHETER CO-R6 (RAIDEN3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2025