PMA2026-09-04
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.
32917510(k)
946PMA
10527Companies
10368Trials
Latest Trends
During this period, 32917 medical devices received FDA 510(k) clearance and 946 devices received Premarket Approval (PMA) . Top categories: LLZ (811 devices), GEX (635 devices), GEI (585 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (253), Boston Scientific Corporation (182), Arthrex, Inc. (174).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-09-04
Implant, cochlear
View Details →PMA2026-09-04
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
View Details →PMA2026-09-04
Acid, hyaluronic, intraarticular
View Details →PMA2026-09-04
Tissue graft of 6mm and greater
View Details →PMA2026-09-04
Next generation sequencing oncology panel, somatic or germline variant detection system
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
NUH2026-09-06
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)
View Details →OBP2026-09-06
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
View Details →QPB2026-09-05
LipoSurg ARTIST
View Details →MLY2026-09-05
FreezeSpray TA
View Details →MYE2026-09-04
Gastric Alimetry
View Details →LLZ2026-09-04
3D-RD-S
View Details →KCT2026-09-04
Surgical and Prosthetic Trays
View Details →EZL2026-09-04
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
View Details →JAK2026-09-04
FCT iStream Phase 2
View Details →QJP2026-09-04
70 NeuGlide Catheter
View Details →QVF2026-09-04
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
View Details →PGW2026-09-04
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)
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-3057-2026
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1
View on 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-3046-2026