PMA2026-09-25
FDA Medical Device Regulatory Records
Daily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. Free to search.
33148510(k)
949PMA
10584Companies
11370Trials
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Latest Trends
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).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-09-25
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
View Details →PMA2026-09-25
Implantable cardioverter defibrillator (non-CRT)
View Details →PMA2026-09-25
Implantable cardioverter defibrillator (non-CRT)
View Details →PMA2026-09-25
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
View Details →PMA2026-09-25
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
N/A2026-09-27
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)
View Details →NKB2026-09-27
Kentrospine Viktr-MIS® Pedicle screw system
View Details →JKA2026-09-25
Profoject™ Safety Sliding Blood Collection Set
View Details →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
View Details →DRT2026-09-25
DistaSense(TM) (v1)
View Details →QZF2026-09-25
CapsoView (CVV); CapsoCloud (CLD)
View Details →IYN2026-09-25
EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
View Details →SBQ2026-09-25
Tempus ECG-MR
View Details →PNN2026-09-25
Invisalign System
View Details →DPS2026-09-25
S-Patch CardioAI
View Details →PHZ2026-09-25
Aevice Wheeze Detection Module
View Details →SHW2026-09-25
TumorSight Risk
View Details →Latest PubMed Research
Recent medical device publications from PubMed / NCBI
Radiation Oncology Device Recalls (2015-2025): Software and Artificial Intelligence as Emerging Drivers of Postmarket Safety.
Read More →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
Read More →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
Read More →Regulating cell and xeno-transplants: Learning from medical device oversight.
Read More →Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.
Read More →Networked Radiology Imaging and Treatment Planning Systems and FDA Cybersecurity Regulation: A Difference-in-Differences Analysis of 510(k) Clearance Delays.
Read More →FDA Medical Device Recalls
Latest recalls and safety alerts from FDA
Class IIZ-3183-2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOL
View on FDA →Class IIZ-3057-2026
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1
View on FDA →Class IIZ-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000
View on FDA →Class IIZ-3046-2026
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item
View on FDA →Class IIZ-3047-2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
View on FDA →Class IIZ-3192-2026