19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
FDA 510(k)
FDA Class 2
·Radiology
TARRY MEDICAL TEMPERATURE PROBES
FDA 510(k)
FDA Class 2
·General Hospital
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·September 27, 2016
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·January 21, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 27, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 31, 2014
ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 10, 2022
LILLIPUT 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·November 3, 2023
PHENOM
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 21, 2023
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·October 30, 2013