PMA2026-09-25
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.
33148510(k)
949PMA
10332Companies
11637Trials
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Latest Trends
During this period, 33148 medical devices received FDA 510(k) clearance and 949 devices received Premarket Approval (PMA) . Top categories: LLZ (816 devices), GEX (644 devices), GEI (589 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (255), Boston Scientific Corporation (184), Arthrex, Inc. (176).
Latest FDA PMA Approvals
Most recent Premarket Approval decisions
PMA2026-09-25
implantable pacemaker Pulse-generator
View Details →PMA2026-09-25
Implantable cardioverter defibrillator (non-CRT)
View Details →PMA2026-09-25
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
View Details →PMA2026-09-25
System, hemodynamic, implantable
View Details →PMA2026-09-25
Transvenous temporary phrenic nerve stimulator
View Details →Latest FDA 510(k) Clearances
Most recent medical device clearances
N/A2026-09-27
Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
View Details →NKB2026-09-27
Kentrospine Viktr-MIS® Pedicle screw system
View Details →SBQ2026-09-25
Tempus ECG-MR
View Details →IYN2026-09-25
EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
View Details →QIH2026-09-25
syngo.CT Brain Quantification
View Details →JKA2026-09-25
Profoject™ Safety Sliding Blood Collection Set
View Details →GDW2026-09-25
easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges
View Details →DRT2026-09-25
DistaSense(TM) (v1)
View Details →QZF2026-09-25
CapsoView (CVV); CapsoCloud (CLD)
View Details →PNN2026-09-25
Invisalign System
View Details →SHW2026-09-25
TumorSight Risk
View Details →OHT2026-09-25
Braun Aura 9 (6042)
View Details →Latest PubMed Research
Recent medical device publications from PubMed / NCBI
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 →Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
Read More →Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.
Read More →Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
Read More →Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.
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-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 IIZ-3133-2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
View on FDA →Class IIZ-3110-2026