19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
FDA 510(k)
FDA Unclassified
·Unknown
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704268683·
SYSTEM WASHER 100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DLX
FDA 510(k)
FDA Class 2
·Radiology
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·February 19, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·May 5, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·December 30, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·February 12, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·May 30, 2025
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 4, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 4, 2011
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 21, 2014
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·January 14, 2026
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·June 27, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·August 11, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·May 14, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·February 3, 2025
STONETOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LQR·March 11, 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