14 results · 26ms · Sources: EU EUDAMED, 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