13 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271937·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304465749·
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D
FDA 510(k)
FDA Class 2
·Radiology
MIDMARK IQECG
FDA 510(k)
FDA Class 2
·Cardiovascular
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·March 24, 2026
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
COULTER GEN-S SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKL·July 8, 2011
BEND-SCR F/UNILOCK-RECOPL TI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 22, 2013
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024
BD SYRINGE 50CC LL TIP CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·January 29, 2025
BD SYRINGE 50CC LL TIP CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·January 29, 2025
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017