510(k) Premarket Notification | 合法醫療器材資訊網
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
Learn more...[1]
References Learn more... (www.fda.gov)
"PRO-MED" BONE FILE (Non-Sterile) "PRO-MED" BONE FILE (Non-Sterile) Covidien balloon dissector Merz merz aesthetics台灣 歐強骨板 歐強醫療 吉富集團 MyLab Gamma HOYA 250
510(k) Premarket Notification | 合法醫療器材資訊網
Ohne Namen | 合法醫療器材資訊網
by PRO-MED Instrumente GmbH D-78532 Tuttlingen Germany 2000 10/09 ... 2 Bone Surgery / Neuro Surgery / Micro Surgery. 3 Thorax / Cardiovascular. 4 Stomach ... Nagelfeilen / Nail-files / Limes à ongles / Limas de uñas / Lime per le unghie ... nicht steril Read More
Ohne Namen | 合法醫療器材資訊網
by PRO-MED Instrumente GmbH D-78532 Tuttlingen Germany 2000 10/09 ... 2 Bone Surgery / Neuro Surgery / Micro Surgery. 3 Thorax / Cardiovascular. 4 Stomach ... Nagelfeilen / Nail-files / Limes à ongles / Limas de uñas / Lime per le unghie ... nicht steril Read More
Primary ID Brand Name Company Name Version or Model ... | 合法醫療器材資訊網
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung. 5011.232 ... IPN016609. Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile. Primary: ... FD833B. Bone file/rasp, manual. Read More
PRO | 合法醫療器材資訊網
sterilisation / sterilization / stérilisation / esterilisación / sterilizzazione ... nasal speculum. tongue blade holder. throat mirrors no 3 and 4. bent arm illuminator. Read More
Public Access Database for Medical Device ... | 合法醫療器材資訊網
大雅儀器有限公司 | 合法醫療器材資訊網
WONDERFUL INSTRUMENTS COMPANY, LTD. 統編34261355 代表人林器愷電話:02-27001787 臺北市大安區復興南路2段160巷2號7樓. 7FL., NO. 2, LANE 160 ... Read More
醫療器材許可證資料集 | 合法醫療器材資訊網
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【"普美" 骨銼 (未滅菌)】許可證字號:衛署醫器輸壹字第001499號
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