31 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Phantom Small Bone Intramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
AURAVUE PIT & FISSURE SEALANT
FDA 510(k)
FDA Class 2
·Dental
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 5, 2025
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·September 12, 2019
BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 14, 2023
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·July 21, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 14, 2013
SENTINEL REAMER 8.0MM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HTO·September 10, 2008
STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 1, 2021
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024
M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 22, 2024
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 12, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·March 8, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 18, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 3, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2020
MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2023