21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Pointe Scientific Creatinine Kinase (CK) Reagent Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bernafon
FDA UDI
Bernafon AG·05711584086308·ZR1 MNR, 2.4G NFM PB MAC ZERENA 1
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
FDA 510(k)
FDA Class 2
·Orthopedic
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025
CONTOUR® XT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
SROM*STM ST,36+8L NK,18X13X160
FDA Adverse Event
Injury
·9616671 DEPUY IRELAND·Product code JDI·June 26, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·July 28, 2011
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026
CONTOUR® XT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025
BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 22, 2020
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
CONTOUR® PLUS
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 4, 2025
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018