23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTRAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MULTI ADJUSTABLE FACE MASK
FDA 510(k)
FDA Class 2
·Dental
EDWARDS ESHEATH+ INTRODUCER SET
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022
UNKNOWN EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026
TF SHEATH UNKNOWN
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023
UNKNOWN EDWARDS LIFESCIENCES SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 1, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 20, 2017
ESHEATH INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021
UNKNOWN EDWARDS LIFESCIENCES SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024
UNKNOWN EDWARDS INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·May 20, 2025
EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022
UNKNOWN EDWARDS INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023
EDWARDS TRANSFEMORAL SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021