19 results · 22ms · Sources: EU EUDAMED, US FDA

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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