PMA2026-08-28
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.
32848510(k)
946PMA
10513Companies
10297Trials
Latest Trends
During this period, 32848 medical devices received FDA 510(k) clearance and 946 devices received Premarket Approval (PMA) . Top categories: LLZ (810 devices), GEX (633 devices), GEI (584 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (182), Arthrex, Inc. (173).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-08-28
Coronary drug-eluting stent
View Details →PMA2026-08-28
Implant, dermal, for aesthetic use
View Details →PMA2026-08-28
Implant, dermal, for aesthetic use
View Details →PMA2026-08-28
System, appendage closure, left atrial
View Details →PMA2026-08-28
Acid, hyaluronic, intraarticular
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
HTY2026-08-28
Primal K-Wire (P99-193-1410)
View Details →PGX2026-08-28
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
View Details →PDU2026-08-28
Kiba CTO Crossing Catheter
View Details →MHX2026-08-28
Carescape Canvas 1000; Carescape Canvas Smart Display
View Details →OZN2026-08-28
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)
View Details →MXD2026-08-28
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
View Details →HRS2026-08-28
FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)
View Details →NRY2026-08-28
Tigertriever 13 Ultra Revascularization Device
View Details →LPH2026-08-28
Mpact 3D Metal Foam
View Details →MQL2026-08-28
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
View Details →NUV2026-08-28
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
View Details →KNW2026-08-28
Automatic Core Biopsy Instrument
View Details →Latest PubMed Research
Recent medical device publications from PubMed / NCBI
Privacy policies for FDA-authorized or FDA-recognized digital therapeutics impose high digital health literacy demands: a cross-sectional analysis.
Read More →Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication.
Read More →Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.
Read More →QAI/ML-SaMD: A Hybrid Health-Technology Quantifiable Quality Metric for Artificial Intelligence/Machine Learning-Based Software as a Medical Device.
Read More →Clinical Specialty Expansion of AI-Enabled and Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysis.
Read More →Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.
Read More →FDA Medical Device Recalls
Latest recalls and safety alerts from FDA
Class IIZ-2953-2026
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway De
View on FDA →Class IIZ-3029-2026
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS98203
View on FDA →Class IIZ-2914-2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, se
View on FDA →Class IIZ-2945-2026
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Numbe
View on FDA →Class IIZ-2919-2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX
View on FDA →Class IIZ-3028-2026