14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDO CLIP III 5MM CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062666·COMPRESSION HIP SCREW SUPER LAG SCREW 125MM
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383576505·Gutta Percha Points is used to root canal filin...
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
FDA 510(k)
FDA Class 2
·General Hospital
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 29, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 30, 2013
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 20, 2013
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MFG·Product code FKX·July 28, 2014
AML PLUS 56MM GR2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDL·June 1, 2011
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021