8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MicroSTAAR Injector System Cartridges
FDA 510(k)
FDA Class 1
·Ophthalmic
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
LUCIA
FDA 510(k)
FDA Class 2
·Physical Medicine
GENISTRONG
FDA Adverse Event
Malfunction
·GENICON·Product code GCJ·October 15, 2017
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·June 5, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 23, 2011
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·October 10, 2014
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