FDA Medical Device Database | 合法醫療器材資訊網

2021年3月3日—CDRHDatabases:alistingofdatabasesforsuchtopicsasadvisorycommittees,regulations,goodpractices,medicaldevices, ...,FDAregulatesthesaleofmedicaldeviceproductsintheU.S.andmonitorsthesafetyofallregulatedmedicalproducts.,2021年2月1日—WhenamedicaldeviceviolatesFDAlaw,FDAcantakeactiontoenforcecomplianceandensurepublichealth.TwomaintoolsareWarningLetters ...,A510(K)isapremarketsubmissionmadetoFDAtodemonstratethatthedevicetobemarketedisassafeandeffective,thatis,substantiallyequivalent, .....

FDA medical device Database FDA Listing database FDA 510k FDA Medical Device Guidance FDA Medical Device classification fda 510k是什麼 FDA Class 2 medical device FDA clearance fda 510k是什麼 fda 510k認證 fda 510k口罩 fda 510k手套 fda 510k查詢 fda 510k費用 fda 510k認證口罩 510k exempt 510k申請 510k豁免 FDA 510k FDA Class 2 medical device FDA medical device fda class 1口罩 Fda class I medical devices FDA medical device Approval Medical device Medical device classification FDA medical device definition fda clearance中文 510(k) exempt fda cleared意思 fda listing number是什麼 FDA Listing database fda查詢 FDA Guidance FDA database FDA number tracking FDA Medical Device classification FDA medical device Database FDA Medical Device Guidance FDA clearance 血漿分離術洗腎針頭大小醫療針頭製造商 "巴諦歐" 凝膠座墊 (未滅菌) 台中髖關節權威 BeGraft Viabahn stent “芮杜拉”可吸收硬腦(脊)膜補片

FDA Medical Device Databases | 合法醫療器材資訊網

2021年3月3日 — CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, ... Read More

Medical Devices | 合法醫療器材資訊網

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. Read More

Search Databases | 合法醫療器材資訊網

2021年2月1日 — When a medical device violates FDA law, FDA can take action to enforce compliance and ensure public health. Two main tools are Warning Letters ... Read More

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, ... Read More

Medical Device Databases | 合法醫療器材資訊網

Medical Device Databases. Print; Share 1; E-mail 2. FDA Home3. -. For information on CDRH Databases, please visit:. Read More

Establishment Registration & Device Listing | 合法醫療器材資訊網

This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA. Note: Registration of a device establishment, ... Read More

Product Classification Database | 合法醫療器材資訊網

a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. learn ... Read More

Premarket Approval (PMA) | 合法醫療器材資訊網

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Read More

Medical Device Recalls | 合法醫療器材資訊網

This database contains Medical Device Recalls classified since November 2002. ... FDA recall classification may occur after the firm recalling the medical ... Read More

相關資訊整理

FDA Medical Device Database | 合法醫療器材資訊網

FDA Medical Device Databases | 合法醫療器材資訊網

Medical Devices | 合法醫療器材資訊網

Search Databases | 合法醫療器材資訊網

510(k) Premarket Notification | 合法醫療器材資訊網

Medical Device Databases | 合法醫療器材資訊網

Establishment Registration & Device Listing | 合法醫療器材資訊網

Product Classification Database | 合法醫療器材資訊網

Premarket Approval (PMA) | 合法醫療器材資訊網

Medical Device Recalls | 合法醫療器材資訊網

【"壹誠"一般手術用手動式器械(滅菌)】許可證字號:衛部醫器製壹字第005207號

【“富爾彬”外科手術用攝影機 (未滅菌)】許可證字號:衛部醫器輸壹字第013911號

【“康泰健”成型牙冠(未滅菌)】許可證字號:衛署醫器輸壹字第011657號

【“克洛瑪”菲瑞斯公主玻尿酸】許可證字號:衛部醫器輸字第026879號

【尼普洛注射筒泵浦】許可證字號:衛署醫器輸字第007826號

【立適美牙科手術裝置及其附件 (未滅菌)】許可證字號:衛署醫器製壹字第004328號

【內植用心臟整律器】許可證字號:衛署醫器輸字第000173號

【"怡貝明" 醫學影像傳輸裝置 (未滅菌)】許可證字號:衛部醫器製壹字第006085號

【“索羅格”血液幫浦控制裝置】許可證字號:衛署醫器輸字第018559號

【"吉達" 體外診斷用血液混合器 (未滅菌)】許可證字號:衛署醫器輸壹字第007416號

【“眼力健”愛鷹視雷射屈光矯正評估工作站】許可證字號:衛部醫器輸字第032898號

【"巨賈" 矯正鏡片 (未滅菌)】許可證字號:衛部醫器製壹字第006292號

【"美敦力" 茵得芙釋放型冠狀動脈支架系統】許可證字號:衛署醫器輸字第017607號

【"坤日"保護性限制帶(未滅菌)】許可證字號:衛署醫器製壹字第003905號

【"修曲" 一般手術用手動式器械 (未滅菌)】許可證字號:衛部醫器輸壹字第020189號

【“奧林柏斯”電子式大腸鏡及其附件】許可證字號:衛部醫器輸字第030836號

【“茂生”吸取裝置 (未滅菌)】許可證字號:衛署醫器製壹字第001574號

【“愛科來”X-血糖儀】許可證字號:衛署醫器輸字第021352號

【東耀酮類驗尿卡(未滅菌)】許可證字號:衛署醫器製壹字第002865號

【“泰利福”陶德手術膽管顯影導管】許可證字號:衛部醫器輸字第031061號

【"萬力"數位模擬攝影機】許可證字號:衛署醫器輸字第017389號

【"綠十字" 醫用膠布 (未滅菌)】許可證字號:衛署醫器陸輸壹字第000160號

【“豪洛捷”子宮頸陰道採樣棉棒套組 (滅菌)】許可證字號:衛部醫器輸壹字第013637號

【“永猷”醫療用口罩(未滅菌)】許可證字號:衛署醫器製壹字第002598號

【"山蒲"牙科手用器械 (未滅菌)　】許可證字號:衛署醫器輸壹字第009575號

【"天暉" 假牙清潔錠 (未滅菌)】許可證字號:衛署醫器輸壹字第011582號

【“柯惠”連續加壓系統】許可證字號:衛部醫器輸字第026125號

【“百脫克”子宮灌注操縱套管】許可證字號:衛部醫器製字第006768號

【"史耐輝" 腹腔鏡及其附件】許可證字號:衛署醫器輸字第014290號

【“美敦力”多點螺旋腎交感神經阻斷導管】許可證字號:衛部醫器輸字第028712號