免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

一次性針筒，針頭永久性固定，安全針筒，針頭永久性固定

K 號：K221308 · 2022-10-17

申請人Jiangxi Maidikang Medical Devices Co., Ltd.
決定日期2022-10-17
產品代碼FMF
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Maidikang Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221308. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Jiangxi Maidikang Medical Devices Co., Ltd.. The 510(k) number is K221308.

When did Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle receive FDA 510(k) clearance?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221308.

Who is the listed applicant for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

The FDA 510(k) record lists Jiangxi Maidikang Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

The FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is FMF.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：FMF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262581GraftGun 適用性移植輸送系統 (GDS®)SurGenTec, LLCK252184SOL-M 輪狀釋放針筒配可交換針盤Sol-Millennium Medical, Inc.K253747一次性針筒注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208超細™ 安全胰島素針embecta Medical II, LLCK253110溶滑安全針；溶滑安全針搭配針筒Sol-Millennium Medical, Inc.K260514Profoject™ 安全針；Profoject™ 配有安全針的注射器；Profoject™ 低死腔配有安全針的注射器CMT Health PTE., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑