14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·May 28, 2025
MODIFIED DISTAL RADIUS PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLOSENSE II, MODEL 29-8040
FDA 510(k)
FDA Class 2
·Anesthesiology
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 22, 2026
AQUASIL ULTRA
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code ELW·November 14, 2008
CADD HIGH-VOLUME ADMINISTRATION SETS
FDA Adverse Event
Injury
·SMITHS MEDICAL·Product code FPA·August 26, 2011
ALIGN S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·July 16, 2013
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·June 2, 2025
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·September 11, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025