PMA2026-09-25
FDA医療機器規制記録
公式政府APIから毎日更新されるFDA 510(k)承認、PMA承認、臨床試験データ、およびバイオメディカル文献。無料で検索可能。
33148510(k)
949PMA
10332企業数
11425試験
AIアシスタント
MedTracker独自のFDA、ClinicalTrials.gov、PubMedの記録のみに基づいて回答する無料のAIアシスタント。見つからない場合は推測せずにその旨を伝えます。
最新の動向
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).
最新のFDA PMA承認
最新の市場投入前承認（PMA）決定
PMA2026-09-25
Implantable cardioverter defibrillator (non-CRT)
詳細を見る →PMA2026-09-25
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
詳細を見る →PMA2026-09-25
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
詳細を見る →PMA2026-09-25
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
詳細を見る →PMA2026-09-25
System, hemodynamic, implantable
詳細を見る →最新のFDA 510(k) 承認
最新の医療機器承認
該当なし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)
詳細を見る →NKB2026-09-27
Kentrospine Viktr-MIS® Pedicle screw system
詳細を見る →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
詳細を見る →JKA2026-09-25
Profoject™ Safety Sliding Blood Collection Set
詳細を見る →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
詳細を見る →DRT2026-09-25
DistaSense(TM) (v1)
詳細を見る →QZF2026-09-25
CapsoView (CVV); CapsoCloud (CLD)
詳細を見る →SBQ2026-09-25
Tempus ECG-MR
詳細を見る →PNN2026-09-25
Invisalign System
詳細を見る →DPS2026-09-25
S-Patch CardioAI
詳細を見る →PHZ2026-09-25
Aevice Wheeze Detection Module
詳細を見る →SHW2026-09-25
TumorSight Risk
詳細を見る →最新のPubMed研究
PubMed / NCBIにおける医療機器関連論文
India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.
続きを読む →Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
続きを読む →Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.
続きを読む →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
続きを読む →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
続きを読む →Regulating cell and xeno-transplants: Learning from medical device oversight.
続きを読む →FDA医療機器リコール
FDAの最新リコールおよび安全アラート
Class IIZ-3183-2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOL
FDAで表示 →Class IIZ-3057-2026
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1
FDAで表示 →Class IIZ-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000
FDAで表示 →Class IIZ-3046-2026
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item
FDAで表示 →Class IIZ-3047-2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
FDAで表示 →Class IIZ-3192-2026