27 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flo Trac sensor, Volume View sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY GLUCOSE CONTROL, MODEL 2120031
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2014
MEDTRONIC.KAPPA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 8, 2013
SYNCHROMED II
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LKK·June 17, 2011
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 30, 2022
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·March 18, 2026
METACROSS OTW PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 19, 2019
OHICHO NEO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 7, 2024
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·December 26, 2019
ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
FDA Adverse Event
Injury
·AESCULAP AG·Product code HBC·October 28, 2018
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
PTA BALLOON CATHETER(OHICHO3)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·December 13, 2017
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 14, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 30, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 27, 2024
ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HBC·November 5, 2018