7 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
GE HealthCare OEC 9800.
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·September 3, 2025
GE HealthCare OEC 9900 Elite C-arm Systems.
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·September 3, 2025
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
FDA Enforcement
Class II
·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
FDA Enforcement
Class II
·Ongoing·Skytron, Div. The KMW Group, Inc·June 23, 2021
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
FDA Enforcement
Class II
·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020