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

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GYNEX EXTENDED REACH NEEDLE

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

SunTech

FDA UDI
SUNTECH MEDICAL, INC.·10840935108887·

MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

FDA 510(k)
FDA Class 2 ·Cardiovascular

TESIO LOCK RIGHT ADAPTOR

FDA Adverse Event
Death ·MED COMP·Product code LFJ·May 18, 1998

RD SET YI

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

M-LNCS DC-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

M-LNCS DC-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

RADICAL-7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

RAD-57 CONFIGURABLE PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

VENTRICULAR ASSIST DEVICE

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·February 2, 2011

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·July 2, 2014

RAINBOW RC-4

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 14, 2023