9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·November 26, 2025
American Contract Systems Biopsy Drape Pack convenience kit
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·August 14, 2024
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·August 14, 2024
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·November 12, 2025
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 18, 2025
American Contract Systems Special Procedure Pack convenience kit
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·August 14, 2024
American Contract Systems Gyn Laparoscopy convenience kit
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·August 14, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
FDA Enforcement
Class II
·Ongoing·BioFire Diagnostics, LLC·August 7, 2024
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 18, 2025