17 results · 23ms · Sources: EU EUDAMED, US FDA

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Edi Catheter ENFit

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

MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

G-PROX EZ ENDOSCOPIC GRASPER

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

I-STAT CG8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

AXIOS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

AXIOS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

PROTECTA DR

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

AXIOS?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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