16 results · 21ms · Sources: EU EUDAMED, 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