PMA2026-09-25
美國 FDA 醫療器材監管記錄
每日更新美國 FDA 510(k) 許可、PMA 核准、臨床試驗資料及生物醫學文獻，來源為政府官方 API。免費查詢。
33148510(k)
949PMA
10332公司
11425試驗
AI 助理
這是一款免費 AI 助理，僅根據 MedTracker 自有之 FDA、ClinicalTrials.gov 和 PubMed 記錄回答。若找不到某項資料，它會如實告知，而非猜測。
最新趨勢
During this period, 33148 medical devices received FDA 510(k) clearance and 949 devices received Premarket Approval (PMA) . Top categories: LLZ (816 devices), GEX (644 devices), GEI (589 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (255), Boston Scientific Corporation (184), Arthrex, Inc. (176).
最新 FDA PMA 核准
最近期預-market 核准決策
PMA2026-09-25
Implantable cardioverter defibrillator (non-CRT)
查看詳情 →PMA2026-09-25
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
查看詳情 →PMA2026-09-25
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
查看詳情 →PMA2026-09-25
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
查看詳情 →PMA2026-09-25
System, hemodynamic, implantable
查看詳情 →最新 FDA 510(k) 許可
最近期的醫療器材許可
不適用2026-09-27
Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
查看詳情 →NKB2026-09-27
Kentrospine Viktr-MIS® Pedicle screw system
查看詳情 →IYN2026-09-25
EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System
查看詳情 →JKA2026-09-25
Profoject™ Safety Sliding Blood Collection Set
查看詳情 →GDW2026-09-25
easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges
查看詳情 →DRT2026-09-25
DistaSense(TM) (v1)
查看詳情 →QZF2026-09-25
CapsoView (CVV); CapsoCloud (CLD)
查看詳情 →SBQ2026-09-25
Tempus ECG-MR
查看詳情 →PNN2026-09-25
Invisalign System
查看詳情 →DPS2026-09-25
S-Patch CardioAI
查看詳情 →PHZ2026-09-25
Aevice Wheeze Detection Module
查看詳情 →SHW2026-09-25
TumorSight Risk
查看詳情 →最新 PubMed 研究
PubMed / NCBI 最近期醫療器材相關出版物
India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.
閱讀更多 →Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
閱讀更多 →Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.
閱讀更多 →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
閱讀更多 →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
閱讀更多 →Regulating cell and xeno-transplants: Learning from medical device oversight.
閱讀更多 →FDA 醫療器材召回
FDA 最新召回與安全警示
Class IIZ-3183-2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOL
在 FDA 網站檢視 →Class IIZ-3057-2026
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1
在 FDA 網站檢視 →Class IIZ-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000
在 FDA 網站檢視 →Class IIZ-3046-2026
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item
在 FDA 網站檢視 →Class IIZ-3047-2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
在 FDA 網站檢視 →Class IIZ-3192-2026