9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482660·INSTRUMENT 6860484 LOCKSCREW DRIVER
ERBE VIO ESU, MODEL VIO 300 D
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Optetrak Advanced Patella
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
EVA BAG-500ML
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SAO PAULO·Product code BTC·October 7, 2010
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 22, 2015
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024
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