11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Magseed Magnetic Marker Systtem
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DERMAPAL WITH DIGITAL TIMER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE BLLOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
STRATA® II VALVE, REGULAR
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·October 15, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
NV EHXL ALIP LNR G4 36MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 18, 2022
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013