PMA2026-09-25
FDA医疗器械监管记录
每日更新FDA 510(k)上市前通告、PMA审批、临床试验数据及官方政府API生物医学文献。免费检索。
33148510(k)
949PMA
10332企业数量
11425临床试验
AI 助手
一款免费的人工智能助手，仅依据MedTracker自身的FDA、ClinicalTrials.gov和PubMed记录作答。当无法找到相关信息时，它会明确告知，而非猜测。
最新趋势
在此期间，33148个医疗设备获得了FDA 510(k)批准，949个设备获得了上市前批准（PMA）。主要类别：LLZ（816个设备），GEX（644个设备），GEI（589个设备）。最活跃的申请人：Siemens Medical Solutions USA, Inc.（255），Boston Scientific Corporation（184），Arthrex, Inc.（176）。
最新FDA PMA批准
最新上市前批准决定
PMA2026-09-25
植入式心脏转复除颤器（非CRT）
查看详情 →PMA2026-09-25
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
查看详情 →PMA2026-09-25
脉冲发生器，起搏器，植入式，具有心脏再同步（CRT-P）
查看详情 →PMA2026-09-25
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
查看详情 →PMA2026-09-25
系统，血流动力学，植入式
查看详情 →最新FDA 510(k)许可
最新医疗器械许可
不适用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)
查看详情 →NKB2026-09-27
Kentrospine Viktr-MIS® Pedicle screw system
查看详情 →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
查看详情 →JKA2026-09-25
Profoject™ Safety Sliding Blood Collection Set
查看详情 →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
查看详情 →DRT2026-09-25
DistaSense(TM) (v1)
查看详情 →QZF2026-09-25
CapsoView (CVV); CapsoCloud (CLD)
查看详情 →SBQ2026-09-25
Tempus ECG-MR
查看详情 →PNN2026-09-25
Invisalign® 系统
查看详情 →DPS2026-09-25
S-Patch CardioAI
查看详情 →PHZ2026-09-25
Aevice Wheeze Detection Module
查看详情 →SHW2026-09-25
TumorSight Risk
查看详情 →最新PubMed研究
PubMed/NCBI收录的最新医疗器械出版物
India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.
阅读更多 →Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
阅读更多 →Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.
阅读更多 →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
阅读更多 →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
阅读更多 →Regulating cell and xeno-transplants: Learning from medical device oversight.
阅读更多 →FDA 医疗器械召回
FDA最新召回及安全警示
II类Z-3183-2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOL
在 FDA 查看 →II类Z-3057-2026
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1
在 FDA 查看 →II类Z-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000
在 FDA 查看 →II类Z-3046-2026
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item
在 FDA 查看 →II类Z-3047-2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
在 FDA 查看 →II类Z-3192-2026