15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Radiographic System Challenge X
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CALIBER SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·December 15, 2022
CONNECTOR SET FOR CANNULAE Ø 6/ 9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·July 14, 2022
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 5, 2011
ETHICON
FDA Adverse Event
Injury
·ETHICON·Product code GAG·June 26, 2013
VISUALASE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code GEX·August 16, 2022
GORE® ACUSEAL VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·December 19, 2022
GORE® PROPATEN® VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·December 19, 2022
GORE® ACUSEAL VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·December 19, 2022
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025