14 results · 22ms · Sources: EU EUDAMED, 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