Becton, Dickinson and Company is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Becton, Dickinson and Company - FDA 510(k) Cleared Devices
Recent clearances: BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes, BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube, BD Vacutainer® Safety-Lok™ Blood Collection Set
Becton, Dickinson and Company, is an American multinational medical technology company headquartered in Franklin Lakes, New Jersey. BD manufactures and sells medical devices, instrument systems, and reagents globally.
The company maintains a strong FDA 510(k) regulatory record with 134 FDA 510(k) clearances from 134 total submissions spanning 2010 to 2026. BD's cleared devices span multiple categories including microbiology systems, blood collection products, and general hospital devices. The company's latest clearance in 2026 reflects continued innovation and regulatory engagement.
BD's recent FDA 510(k) cleared devices demonstrate expertise across microbiology diagnostics, blood collection and specimen handling, and hospital infusion systems. Notable recent clearances include automated microbiology platforms, blood collection tubes and needles, and diagnostic panels for infectious disease detection.
Explore the complete regulatory history of Becton, Dickinson and Company by reviewing individual device names, product codes, and clearance dates in the database.
Regulatory submissions have been managed by Regulatory Technology Services, LLC and Hogan Lovells US LLP. 1 device has linked clinical trial registered on ClinicalTrials.gov. 3 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Becton, Dickinson and Company
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