17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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