11 results
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34ms
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Sources: EU EUDAMED, US FDA
BILE ENDOPROSTHESIS SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471159297·SAGITTAL BLADE - DE SOUTTER STANDARD 9 x 25 x 0...
DeSoutter
FDA UDI
Provision·B504OMS8605340·
DeSoutter
FDA UDI
Provision·00810041638236·
MODEL 52 BUNN DRY AIR SUPPLY
FDA 510(k)
FDA Class 2
·Anesthesiology
INTUITIVE SURGICAL SEAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·December 5, 2012
EVA BAG-500ML
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SAO PAULO·Product code BTC·October 7, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012