PMA2026-07-09
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.
32417510(k)
940PMA
10413Companies
8083Trials
Latest Trends
During this period, 32417 medical devices received FDA 510(k) clearance and 940 devices received Premarket Approval (PMA) . Top categories: LLZ (802 devices), GEX (625 devices), GEI (580 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (178), Arthrex, Inc. (171).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-07-09
Drug-coated peripheral transluminal angioplasty catheter
View Details →PMA2026-07-09
Embolization Agent, Vascular
View Details →PMA2026-07-09
Scaffold, infrapopliteal, absorbable
View Details →PMA2026-07-09
Implant, dermal, for aesthetic use
View Details →PMA2026-07-08
Device, thermal ablation, endometrial
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
PFO2026-07-10
Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System
View Details →ESW2026-07-10
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
View Details →KNT2026-07-10
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
View Details →FOZ2026-07-10
ClearSafe Closed System
View Details →LLZ2026-07-10
Avara Viewer
View Details →LSR2026-07-10
Sofia Lyme FIA; Sofia 2 Campylobacter FIA
View Details →OWB2026-07-10
SmartCT (R3.0 (L10))
View Details →EOQ2026-07-10
LungFlow Airway Catheter
View Details →LPH2026-07-10
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component
View Details →MQP2026-07-10
POSEIDON ST
View Details →SCA2026-07-10
Flowflex Plus RSV + Flu A/B + COVID Rapid Test
View Details →OLW2026-07-10
SedLine Sedation Monitor
View Details →Latest PubMed Research
Recent medical device publications from PubMed / NCBI
R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27.
Read More →Regulatory science for AI-based software as a medical device in computational pathology and biomarker-driven drug development.
Read More →United States Food and Drug Administration Approval of Neurosurgical Devices: A 25-Year Review of Non-510(k) Pathway Trends.
Read More →Review of regulatory requirements for benefit - risk assessment for medical devices: uncovering existing methodologies.
Read More →Borrowing from the cancer playbook: a master protocol basket trial for hard-to-heal wound therapeutics targeting shared pathobiology.
Read More →Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.
Read More →FDA Medical Device Recalls
Latest recalls and safety alerts from FDA
Class IIZ-2623-2026
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
View on FDA →Class IIZ-2609-2026
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTO
View on FDA →Class IIZ-2646-2026
RayCare 2024A SP1. Oncology Information Systems.
View on FDA →Class IIZ-2656-2026
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609
View on FDA →Class IIZ-2607-2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJO
View on FDA →Class IIZ-2629-2026