PMA2026-09-13
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.
32987510(k)
946PMA
10544Companies
10820Trials
Latest Trends
During this period, 32987 medical devices received FDA 510(k) clearance and 946 devices received Premarket Approval (PMA) . Top categories: LLZ (811 devices), GEX (637 devices), GEI (586 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (254), Boston Scientific Corporation (183), Arthrex, Inc. (174).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-09-11
System, hemodynamic, implantable
View Details →PMA2026-09-11
Stimulator, electrical, implanted, for parkinsonian tremor
View Details →PMA2026-09-11
Stimulator, spinal-cord, totally implanted for pain relief
View Details →PMA2026-09-11
Unknown Device
View Details →PMA2026-09-11
Immunohistochemistry assay, antibody, programmed death-ligand 1
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
FMK2026-09-13
Safety lancet (XL)
View Details →MSX2026-09-12
Digistat Care
View Details →QNP2026-09-12
CADDIE
View Details →GEI2026-09-11
Potenza Prime
View Details →GWO2026-09-11
CraniUS Plate
View Details →FED2026-09-11
Single Use Ureteral Access Sheath
View Details →JWH2026-09-11
GSPE Spacer
View Details →OVD2026-09-11
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System
View Details →GCJ2026-09-11
CuratOR EX2742
View Details →OVB2026-09-11
SpaceOAR Flex™ System
View Details →QJI2026-09-11
iLet Dosing Decision Software
View Details →KPS2026-09-11
MICSI-PET
View Details →Latest PubMed Research
Recent medical device publications from PubMed / NCBI
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 →Artificial Intelligence and the Evolving Standard of Care in Dentistry: Clinical Evidence, Regulatory Landscape, and Medicolegal Implications.
Read More →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 →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-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-3133-2026