13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
FDA 510(k)
FDA Class 2
·Cardiovascular
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IPLAN! DIGITAL TEMPLATING
FDA 510(k)
FDA Class 2
·Neurology
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 15, 2023
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·February 4, 2013
GUT SURGICAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAL·December 23, 2010
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code OUT·July 17, 2014
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·July 26, 2024
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·September 17, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 18, 2019
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024