15 results · 29ms · Sources: EU EUDAMED, US FDA

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VAMP Plus Venous/Arterial Blood Management Protection System

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRUWAVE, VAMP PLUS

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

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

TRUWAVE, VAMP PLUS

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

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025

BLACKSTONE PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HT70 PLUS VENTILATOR

FDA Adverse Event
Malfunction ·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·June 14, 2013

TENDRIL SDX

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·July 27, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 30, 2008

St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 11, 2018