16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Auxein's DHS/DCS Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Enriched Thioglycollate Medium
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902217870·BD BBL™ Enriched Thioglycollate Medium, 8 mL, P...
SEE H.10
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 5, 2023
VISUCAM
FDA 510(k)
FDA Class 1
·Radiology
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
CAPTURE-R READY SCREEN (3)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·March 8, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 17, 2011
ECHELON 60 ENDOPATH STAPLER LONG ENDOSCOPIC LINEAR CUTTER -
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·September 9, 2008
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Injury
·OPTONOL, LTD·Product code KYF·July 9, 2013
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
CONTOUR® NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025
CONTOUR® PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025
BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM
FDA Adverse Event
Injury
·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·January 30, 2025
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 26, 2019