13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·May 29, 2024
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Pacemaker, COPM11B; Medical convenience kit
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·October 2, 2024
Cysto, FTCY03L; Medical convenience kit
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·October 2, 2024
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
FDA Enforcement
Class II
·Ongoing·3M Company - Health Care Business·October 4, 2023
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·August 6, 2025
MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·November 26, 2025
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·June 21, 2023