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Becton, Dickinson and Company

FDA 510(k) & PMA Approved Devices — 100 products

Total Devices100
Categories30
Latest Approval2026-04-15
TypeNumberDevice NameCodeDate
510(k) K260128 BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes JKA 2026-04-15 View
510(k) K252506 BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder JKA 2026-04-10 View
510(k) K252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube JKA 2026-04-10 View
510(k) K260184 Onclarity™ Self-Collection Kit SEP 2026-04-02 View
510(k) K252040 BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes JKA 2026-03-13 View
510(k) K250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe NGT 2025-12-02 View
510(k) K250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System PCI 2025-10-31 View
510(k) K250059 BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) ONB 2025-09-12 View
510(k) K251713 BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) LON 2025-08-08 View
510(k) K251350 BD Plastipak™ Syringe FMF 2025-07-29 View
510(k) K243207 BD Vacutainer® Eclipse™ Blood Collection Needle JKA 2025-07-03 View
510(k) K243872 BD Veritor System for SARS-CoV-2 QVF 2025-06-16 View
510(k) K250447 BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) LON 2025-05-19 View
510(k) K243649 BD Vacutainer® Multiple Sample Luer Adapter JKA 2025-03-21 View
510(k) K250344 BD Phoenix™ Automated Microbiology System LON 2025-03-06 View
510(k) K243725 BD Vaginal Panel PQA 2024-12-19 View
510(k) K242320 BD Vacutainer® One Use Holder JKA 2024-11-01 View
510(k) K240455 BD Vacutainer® Citrate Blood Collection Tubes GIM 2024-10-31 View
510(k) K233986 BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) LON 2024-03-15 View
510(k) K231373 BD Vacutainer® K2 EDTA Blood Collection Tubes JKA 2024-02-02 View
510(k) K231237 BD Vacutainer® Fluoride Blood Collection Tubes JKA 2024-01-19 View
510(k) K230855 BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes JKA 2023-12-20 View
510(k) K230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube JKA 2023-12-01 View
510(k) K230493 BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube GIM 2023-11-27 View
510(k) K222563 BD Kiestra IdentifA QQV 2023-08-31 View
510(k) K213670 BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes GIM 2023-08-25 View
510(k) K231161 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe NGT 2023-07-21 View
510(k) K213953 BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes JKA 2023-07-17 View
510(k) K230651 BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) JTN 2023-06-07 View
510(k) K222559 BD BACTEC™ Myco/F Lytic Culture Vials MDB 2023-03-24 View
510(k) K220212 BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder JKA 2023-03-24 View
510(k) K222591 BD BACTEC™ Plus Aerobic/F Culture Vials MDB 2023-03-24 View
510(k) K222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device JKA 2023-03-10 View
510(k) K223653 BD Vaginal Panel PQA 2023-03-06 View
510(k) K223286 BD AutoShield Duo™ Pen Needle FMI 2022-12-28 View
510(k) K221826 BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) JTN 2022-12-21 View
510(k) K223243 BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets FMK 2022-12-16 View
510(k) K220607 BD MAX Enteric Viral Panel PCH 2022-09-21 View
510(k) K220193 BD MAX Enteric Parasite Panel PCH 2022-08-19 View
510(k) K214122 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel PCI 2022-07-28 View
510(k) K213955 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub QTI 2022-07-16 View
510(k) K211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle BSP 2022-07-01 View
510(k) K213478 BD Pen Needle FMI 2022-06-28 View
510(k) K210983 BD Epilor Syringe CAZ 2022-05-19 View
510(k) K210585 BD CTGCTV2 QEP 2022-05-10 View
510(k) K213616 BD Surgiphor Antimicrobial Irrigation System FQH 2022-03-23 View
510(k) K212499 BD Insulin Syringe (0.3mL) FMF 2022-03-09 View
510(k) K212724 BD Vacutainer UltraTouch Push Button Blood Collection Set JKA 2022-02-04 View
510(k) K210978 BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle BSP 2021-12-22 View
510(k) K213156 BD Nano 2nd Gen Pen Needle FMI 2021-12-08 View
510(k) K212015 BD Nano 2nd Gen Pen Needle FMI 2021-11-19 View
510(k) K191964 BD Kiestra IdentifA QQV 2021-11-03 View
510(k) K203359 BD Flu+ Syringe FMF 2021-07-28 View
510(k) K200891 BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System FOZ 2021-06-02 View
510(k) K203453 BD Hypodermic Syringe FMF 2021-01-25 View
510(k) K201075 BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter FOZ 2020-12-18 View
510(k) K193190 BD PureHub Disinfecting Cap QBP 2020-11-09 View
510(k) K193131 BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle BSP 2020-09-29 View
510(k) K201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit OYE 2020-09-28 View
510(k) K202446 BD Preset Syringe & BD A-Line Syringe JKA 2020-09-25 View
510(k) K192538 BD Syringe NRFit Lok and BD Syringe NRFit Slip QEH 2020-09-04 View
510(k) K201099 BD PhaSeal Optima Closed System Drug Transfer Device ONB 2020-08-12 View
510(k) K201234 BD SoloShot Mini Syringe/ BD Auto Disable Syringe FMF 2020-07-15 View
510(k) K190054 BD Insulin Syringe FMF 2019-10-21 View
510(k) K190905 BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) LON 2019-07-01 View
510(k) K182092 BD Intelliport System PHC 2019-04-30 View
510(k) K182589 BD Plastipak Syringe FMF 2019-03-14 View
510(k) K181730 BD Vacutainer Eclipse UltraFill Blood Collection Needle FMI 2019-03-01 View
510(k) K182692 BD MAX CTGCTV2, BD MAX System OUY 2019-01-08 View
510(k) K182320 BD Contoured Base Pen Needle FMI 2018-12-20 View
510(k) K181221 BD PhaSeal Optima Closed System Transfer Device ONB 2018-11-30 View
510(k) K181427 BD MAX Enteric Viral Panel, BD MAX Instrument PCH 2018-11-29 View
510(k) K172670 BD Single Use, Hypodermic Syringe FMF 2018-10-23 View
510(k) K181718 BD FlowSmart Set/MiniMed Pro-Set FPA 2018-10-18 View
510(k) K181665 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN LON 2018-09-21 View
510(k) K170824 BD Vacutainer Eclipse Signal Blood Collection Needle FMI 2018-08-20 View
510(k) K173873 BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial MDB 2018-03-16 View
PMA P160037 KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ 2018-02-12 View
510(k) K173523 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) LON 2018-02-09 View
510(k) K173252 BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) LON 2018-01-05 View
510(k) K172506 BD Cathena Safety IV Catheter FOZ 2017-09-17 View
510(k) K172204 BD Intima II PLUS Closed IV Catheter System FOZ 2017-08-17 View
510(k) K170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK OYE 2017-07-03 View
510(k) K170308 BD MAX Extended Enteric Bacterial Panel, BD MAX System PCH 2017-05-02 View
510(k) K170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector FOZ 2017-03-10 View
510(k) K170283 BD Nexiva Diffusics Closed IV Catheter System FOZ 2017-02-28 View
510(k) K163591 BD PosiFlush Heparin Lock Flush Syringe NZW 2017-02-27 View
510(k) K161552 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe NGT 2017-02-02 View
510(k) K162081 BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe FMF 2016-12-19 View
510(k) K162516 BD Pen Needle FMI 2016-12-09 View
510(k) K160657 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube JKA 2016-09-23 View
510(k) K151589 BD MAX CT/GC/TV, BD MAX INSTRUMENT OUY 2016-09-06 View
510(k) K151870 BD U-500 INSULIN SYRINGE FMF 2016-07-08 View
510(k) K161553 BD SafeAssist FMI 2016-07-06 View
510(k) K161170 BD Eclipse Hypodermic Needle FMI 2016-05-27 View
510(k) K160651 BD FlowSmart Set, MiniMed Pro-Set FPA 2016-04-07 View
510(k) K153481 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe NGT 2016-04-04 View
510(k) K151866 BD BACTEC Peds Plus/F Culture Vials (plastic) MDB 2016-02-25 View
510(k) K153309 BD Vacutainer UltraTouch Push Button Blood Collection Set JKA 2016-02-12 View
510(k) K151320 BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml LON 2016-01-15 View
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