16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric Wheelchair
FDA 510(k)
FDA Class 2
·Physical Medicine
HEALICOIL SUTURE ANCHOR WITH REGENESORB
FDA 510(k)
FDA Class 2
·Orthopedic
FAST-FIX FLEX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 5, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 6, 2026
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 12, 2013
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 21, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·January 7, 2025
CONTOUR® PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 3, 2025
CONTOUR® PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018