22 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
FDA 510(k)
FDA Unclassified
·Unknown
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515068261·Weitlaner Ret, blunt prng, 2x3, 4"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027183·Weitlaner Ret, blunt prng, 2x3, 4"
FLOWTAIN & FLOWTAIN LV
FDA 510(k)
FDA Class 2
·Dental
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·May 22, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 21, 2013
ECHELON*FLEX45 LONG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 28, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 11, 2026
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 9, 2021
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 10, 2023