16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APOLLO ADVANTAGE Nitrile Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTRODUCER SETS, MODEL ADELANTE RADIAL
FDA 510(k)
FDA Class 2
·Cardiovascular
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·May 28, 2022
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026
MICROLET®
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 25, 2021
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·November 6, 2008
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 12, 2011
COULTER® AC*T DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 16, 2013
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025
MICROLET®
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
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