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

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Zimmon Needle Knife Papillotome

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

T-PORT HP INFUSION PORT

FDA 510(k)
FDA Class 2 ·General Hospital

VIPER SYSTEM, EXPEDIUM SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 28, 2026

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026

PLUM A+ SOFTWARE MODULE, LIST #20791, SN UNK

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 10, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 22, 2011

CONTURA MULTI-LUMEN BALLOON APPLICATOR

FDA Adverse Event
Malfunction ·SENORX·Product code JAQ·September 22, 2008

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·May 9, 2025

TRUWAVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·August 21, 2024

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025

CAPTURA HOT BIOPSY FORCEPS

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024

CONQUEST PRO 12 ST

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025

ASTATO XS 9-12

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021