FDA 510(k) Applications Submitted by Becton, Dickinson and Company

FDA 510(k) Number Submission Date Device Name Applicant
K223243 10/20/2022 BD Microtainer« Contact-Activated Lancets; BD Microtainer« QuikheelÖ Lancets Becton, Dickinson and Company
K170283 01/30/2017 BD Nexiva Diffusics Closed IV Catheter System Becton, Dickinson and Company
K201099 04/24/2020 BD PhaSeal Optima Closed System Drug Transfer Device Becton, Dickinson and Company
K181221 05/07/2018 BD PhaSeal Optima Closed System Transfer Device Becton, Dickinson and Company
K160657 03/08/2016 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube BECTON, DICKINSON AND COMPANY
K150815 03/27/2015 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit Becton, Dickinson and Company
K110703 03/14/2011 BD AUTOSHIELD DUO PEN NEEDLE Becton, Dickinson and Company
K170824 03/20/2017 BD Vacutainer Eclipse Signal Blood Collection Needle Becton, Dickinson and Company
K181730 06/29/2018 BD Vacutainer Eclipse UltraFill Blood Collection Needle Becton, Dickinson and Company
K112774 09/23/2011 BD RECYKLEEN SHARPS COLLECTORS Becton, Dickinson and Company
K101461 05/26/2010 BD DIRECTIGEN EX FLU A+B Becton, Dickinson and Company
K120049 01/06/2012 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company
K121633 06/04/2012 BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV Becton, Dickinson and Company
K112277 08/09/2011 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company
K122718 09/05/2012 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP Becton, Dickinson and Company
K121797 06/19/2012 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company
K132256 07/19/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company
K132259 07/19/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company
K132456 08/06/2013 BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV Becton, Dickinson and Company
K132692 08/29/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company
K132693 08/29/2013 BD VeritorÖ System Flu A+B Assay Becton, Dickinson and Company
K172204 07/21/2017 BD Intima II PLUS Closed IV Catheter System Becton, Dickinson and Company
K172506 08/18/2017 BD Cathena Safety IV Catheter Becton, Dickinson and Company
K100722 03/15/2010 TELAVANCIN 30 UG, BBL SENSI-DISC Becton, Dickinson and Company
K191964 07/23/2019 BD Kiestra IdentifA Becton, Dickinson and Company
K153481 12/03/2015 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe BECTON, DICKINSON AND COMPANY
K130197 01/28/2013 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 Becton, Dickinson and Company
K110771 03/21/2011 BD SINGLE USE, HYPODERMIC SYRINGE Becton, Dickinson and Company
K220193 01/24/2022 BD MAX Enteric Parasite Panel Becton, Dickinson and Company
K220607 03/02/2022 BD MAX Enteric Viral Panel Becton, Dickinson and Company
K243725 12/03/2024 BD Vaginal Panel Becton, Dickinson and Company
K223653 12/06/2022 BD Vaginal Panel Becton, Dickinson and Company
K214122 12/30/2021 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel Becton, Dickinson and Company
K141311 05/20/2014 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE Becton, Dickinson and Company
K250447 02/18/2025 BD PhoenixÖ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 ╡g/mL) Becton, Dickinson and Company
K233986 12/18/2023 BD PhoenixÖ Automated Microbiology System - GN Ciprofloxacin (0.0156û4 ╡g/mL) Becton, Dickinson and Company
K213478 10/29/2021 BD Pen Needle Becton, Dickinson and Company
K250344 02/06/2025 BD PhoenixÖ Automated Microbiology System Becton, Dickinson and Company
K230651 03/09/2023 BD BBLÖ Sensi-DiscÖ Lefamulin 20╡g (LMU-20) Becton, Dickinson and Company
K212724 08/27/2021 BD Vacutainer UltraTouch Push Button Blood Collection Set Becton, Dickinson and Company
K132909 09/17/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) Becton, Dickinson and Company
K182692 09/27/2018 BD MAX CTGCTV2, BD MAX System Becton, Dickinson and Company
K170336 02/02/2017 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector Becton, Dickinson and Company
K200891 04/03/2020 BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System Becton, Dickinson and Company
K201075 04/22/2020 BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter Becton, Dickinson and Company
K121283 04/30/2012 BD EMERALD SAF-T SINGLE USE, HYPODERMIC Becton, Dickinson and Company
K170308 02/01/2017 BD MAX Extended Enteric Bacterial Panel, BD MAX System BECTON, DICKINSON AND COMPANY
K190905 04/08/2019 BD Phoenix Automated Microbiology System û GN Ceftaroline (0.0156-4 ╡g/mL) Becton, Dickinson and Company
K181427 06/01/2018 BD MAX Enteric Viral Panel, BD MAX Instrument Becton, Dickinson and Company
K222563 08/24/2022 BD Kiestra IdentifA Becton, Dickinson and Company
K152516 09/03/2015 BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks BECTON, DICKINSON AND COMPANY
K182589 09/20/2018 BD Plastipak Syringe Becton, Dickinson and Company
K170974 04/03/2017 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 Becton, Dickinson and Company
K151870 07/09/2015 BD U-500 INSULIN SYRINGE BECTON, DICKINSON AND COMPANY
K231237 04/28/2023 BD Vacutainer« Fluoride Blood Collection Tubes Becton, Dickinson and Company
K212499 08/09/2021 BD Insulin Syringe (0.3mL) Becton, Dickinson and Company
K213156 09/20/2021 BD Nano 2nd Gen Pen Needle Becton, Dickinson and Company
K160651 03/08/2016 BD FlowSmart Set, MiniMed Pro-Set BECTON, DICKINSON AND COMPANY
K153257 11/10/2015 BD FlowSmart Set, MiniMed Pro-Set BECTON, DICKINSON AND COMPANY
K161553 06/06/2016 BD SafeAssist BECTON, DICKINSON AND COMPANY
K181718 06/29/2018 BD FlowSmart Set/MiniMed Pro-Set Becton, Dickinson and Company
K182320 08/27/2018 BD Contoured Base Pen Needle Becton, Dickinson and Company
K162516 09/09/2016 BD Pen Needle BECTON, DICKINSON AND COMPANY
K140468 02/25/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) Becton, Dickinson and Company
K142170 08/07/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company
K132674 08/27/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) Becton, Dickinson and Company
K123266 10/19/2012 BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN Becton, Dickinson and Company
K151320 05/18/2015 BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml BECTON, DICKINSON AND COMPANY
K173523 11/14/2017 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) Becton, Dickinson and Company
K151766 06/30/2015 BD Single Use, Hypodermic Syringe BECTON, DICKINSON AND COMPANY
K162081 07/27/2016 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 Becton, Dickinson and Company
K192538 09/16/2019 BD Syringe NRFit Lok and BD Syringe NRFit Slip Becton, Dickinson and Company
K193131 11/12/2019 BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle Becton, Dickinson and Company
K210978 04/01/2021 BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle Becton, Dickinson and Company
K203359 11/16/2020 BD Flu+ Syringe Becton, Dickinson and Company
K201814 07/01/2020 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, Becton, Dickinson and Company
K153309 11/17/2015 BD Vacutainer UltraTouch Push Button Blood Collection Set BECTON, DICKINSON AND COMPANY
K140111 01/15/2014 BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT Becton, Dickinson and Company
K120994 04/02/2012 BD BACTEC Plus PRIME Aerobic/F Culture Vials Becton, Dickinson and Company
K141810 07/07/2014 BD BACTEC PLUS ANAEROBIC/F (PLASTIC) Becton, Dickinson and Company
K113558 12/01/2011 BD BACTEC Plus Aerobic/F Culture Vials (plastic) Becton, Dickinson and Company
K143648 12/22/2014 BD MAX Enteric Parasite Panel, BD MAX Instrument BECTON, DICKINSON AND COMPANY
K161170 04/26/2016 BD Eclipse Hypodermic Needle Becton, Dickinson and Company
K231161 04/24/2023 0.9% Sodium Chloride Injection, USP BD PosiFlushÖ SF Saline Flush Syringe Becton, Dickinson and Company
K211085 04/12/2021 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle Becton, Dickinson and Company
K213616 11/15/2021 BD Surgiphor Antimicrobial Irrigation System Becton, Dickinson and Company
K140447 02/21/2014 BD VIPER LT SYSTEM Becton, Dickinson and Company
K222591 08/26/2022 BD BACTECÖ Plus Aerobic/F Culture Vials Becton, Dickinson and Company
K243872 12/17/2024 BD Veritor System for SARS-CoV-2 Becton, Dickinson and Company
K172670 09/05/2017 BD Single Use, Hypodermic Syringe Becton, Dickinson and Company


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