17 results
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31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASSURE® Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270657·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027312·Weitlaner Ret, shrp prng, 3x4, 9 1/2"
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
FDA 510(k)
FDA Class 2
·Ophthalmic
NEO-STAT CO2 <KG
FDA 510(k)
FDA Class 2
·Anesthesiology
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 28, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·August 13, 2021
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 27, 2022
AMPLATZER AMULET
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NGV·October 7, 2024
COONS DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 28, 2022