19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Libertas Taper Uncemented Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304272118·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304473096·
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VRESELECT CULTURE MEDIUM
FDA 510(k)
FDA Class 2
·Microbiology
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026
TRUWAVE VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025
TRUWAVE VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
M2A-MAGNUM 42-50MM TAPER INSERT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013
UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JGS·July 22, 2011
TRUWAVE, VAMP PLUS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025
CONNECTA WHT 360DEG TB 100CM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 22, 2021
TRUWAVE, VAMP PLUS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024
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