PMA2026-10-09
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.
169749510(k)
951PMA
33556Companies
12154Trials
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Latest Trends
During this period, 169749 medical devices received FDA 510(k) clearance and 951 devices received Premarket Approval (PMA) . Top categories: GEX (2781 devices), GEI (2223 devices), LLZ (2151 devices). Most active applicants: Abbott Laboratories (883), Siemens Medical Solutions USA, Inc. (733), Bd Becton Dickinson Vacutainer Systems Preanalytic (632).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-10-09
Implant, cochlear
View Details →PMA2026-10-09
implantable pacemaker Pulse-generator
View Details →PMA2026-10-09
Implantable cardioverter defibrillator (non-CRT)
View Details →PMA2026-10-09
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
View Details →PMA2026-10-09
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
CAC2026-10-11
Helo™ Return
View Details →HRX2026-10-09
TruVision Single-Use 1.9mm Arthroscopy System
View Details →OHT2026-10-09
IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
View Details →DRF2026-10-09
Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
View Details →MQK2026-10-09
Fertilis microICSI Device
View Details →OAP2026-10-09
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)
View Details →NBW2026-10-09
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.
View Details →OLZ2026-10-09
Sleep Analysis Module
View Details →NPM2026-10-09
Wishbone HAE
View Details →OLO2026-10-09
CarboClear® Cervical Navigated Instruments
View Details →DZJ2026-10-09
CMF Titanium Splints
View Details →LJS2026-10-09
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
View Details →Latest PubMed Research
Recent medical device publications from PubMed / NCBI
Faster but Not Truer, Part 2: The Regulatory Record, the Economics, and the TRACE-HEOR Reporting Standard.
Read More →Artificial Intelligence in Health Insurance: An Interagency Framework for Federal and State Oversight.
Read More →Proceedings from the Consortium for Technology & Innovation in Pediatrics (CTIP) 2025 annual pediatric device innovation symposium.
Read More →Post-market safety signals of energy-based surgical devices: a cross-specialty disproportionality analysis of the FDA MAUDE database with robotic-platform validation and regulatory triangulation, 2015-2025.
Read More →Surgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.
Read More →India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.
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-0004-2027
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LI
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-3192-2026
Et Control, Software option for anesthesia gas machine to achieve and maintain t
View on FDA →Class IZ-3151-2026
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
View on FDA →Class IZ-3228-2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1070
View on FDA →Advertisement