11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
True 3D Viewer Software
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES USS CONNECTORS
FDA 510(k)
FDA Class 2
·Orthopedic
1.5T 16-CHANNEL HAND-WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
VSP SYSTEM
FDA Adverse Event
Injury
·3D SYSTEMS·Product code DZJ·December 18, 2020
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 7, 2008
HIRES 90K IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·June 25, 2013
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code LGW·July 21, 2011
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016