11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive Cohere Thoracolumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
AGXO
FDA UDI
Oticon A/S·05707131343376·G100, MINIRITE T 312 2.4G C063 AGXO
CLEARSTART SVM SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SYNGO.CT NEURO PERFUSION
FDA 510(k)
FDA Class 2
·Radiology
NEEDLE 26X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 2, 2021
NEEDLE 26X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 2, 2021
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
KEY F/PFNA BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·June 27, 2013
STRATOS
FDA Adverse Event
Injury
·MEDXPERT GMBH·Product code HRS·September 11, 2014
BD PRECISIONGLIDE NEEDLE 26G X 1/2 IN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 2, 2020
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023