Class 2 Device Recall Smart Stapes Protheses | 合法醫療器材資訊網
References
Related Medical Device
Recalls (www.accessdata.fda.gov)
K003214
(www.accessdata.fda.gov)
Prosthesis, partial ossicular
replacement (www.accessdata.fda.gov)
ETB
(www.accessdata.fda.gov)
TPLC Device Report
(www.accessdata.fda.gov)
medical device recalls
(www.fda.gov)
Code of Federal Regulations
(CFR) Title 21 §7.55
(www.accessdata.fda.gov)
510(K)s with Product Code = ETB
and Original Applicant = GYRUS ENT L.L.C.
(www.accessdata.fda.gov)
Date Initiated by Firm
July 14, 2020
Create Date
...
“Gyrus”Smart Prostheses “Gyrus”Smart Prostheses Covidien balloon dissector "NMC" LUER LOCK BLOODINE "皙法" 雅米2000 卡巴馬平檢驗試劑 昶驊企業有限公司 輝洋精密工業有限公司 眾陽機械 Clinical Chemistry Clinical Biochemistry PDF
Class 2 Device Recall Smart Stapes Protheses | 合法醫療器材資訊網
Reference Guide - Olympus America | 合法醫療器材資訊網
SMART PISTON | Other Products | 合法醫療器材資訊網
SMART PISTON | Otology Products | ENT | 合法醫療器材資訊網
Urgent Field Safety Notice for Gyrus ACMI Smart Prostheses ... | 合法醫療器材資訊網
YuanYu | 合法醫療器材資訊網
“吉斯”聰明植入物“Gyrus”Smart Prostheses} | 合法醫療器材資訊網
新藥及新醫材意見分享 | 合法醫療器材資訊網
相關資訊整理
【“吉斯”聰明植入物】許可證字號:衛署醫器輸字第018049號
器材品名:“吉斯”聰明植入物許可證字號:衛署醫器輸字第018049號註銷狀態:已註銷註銷日期:2019/11/20註銷理由:許可證已逾有效...