12 results · 20ms · Sources: EU EUDAMED, US FDA

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HUMIDAIRE 2I

FDA 510(k)
FDA Class 2 ·Anesthesiology

RUSCH MILLER-ABBOTT TUBE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01

FDA 510(k)
FDA Class 2 ·Orthopedic

WAVEWRITER ALPHA PRIME 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 26, 2023

INFINION? CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 4, 2026

CELOX GAUZE

FDA Adverse Event
Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

CELOX GAUZE

FDA Adverse Event
Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

PRISMAFLEX M150 SET

FDA Adverse Event
Malfunction ·GAMBRO·Product code FPA·September 5, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 2011

CELOX GAUZE

FDA Adverse Event
Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024