Company · US
Becton Dickinson & Company
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
199510(k) clearances (0 in 12 months)
499recalls (17 in 12 months)
308recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 136 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 76 |
| FMF | Syringe, Piston | 45 |
| JTN | Susceptibility Test Discs, Antimicrobial | 39 |
| FMI | Needle, Hypodermic, Single Lumen | 26 |
| MDB | System, Blood Culturing | 22 |
| FPA | Set, Administration, Intravascular | 15 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 15 |
| CAZ | Anesthesia Conduction Kit | 12 |
| PTI | Non-Coring (Huber) Needle | 12 |
| FMG | Stopcock, I.V. Set | 11 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 11 |
| N/A | 11 | |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 11 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 10 |
| LSL | Dna-Reagents, Neisseria | 10 |
| JSI | Culture Media, Selective And Differential | 9 |
| NBW | System, Test, Blood Glucose, Over The Counter | 9 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 9 |
| MJA | Susceptibility Test Powders, Antimycobacterial | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2025 | K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); Becton Dickinson | PHC |
| Apr 12, 2017 | K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle an Becton Dickinson & Company | FMF |
| Mar 21, 2017 | K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) Becton Dickinson & Company | LON |
| Feb 9, 2017 | K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial Becton Dickinson | MDB |
| Aug 8, 2016 | K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial Becton Dickinson | MDB |
| Feb 25, 2016 | K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit Becton, Dickinson & CO | PSZ |
| Feb 24, 2016 | K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit Becton, Dickinson & CO | PSZ |
| Apr 28, 2015 | K150059 | BD FlowSmart Set Becton, Dickinson Company | FPA |
| Dec 18, 2014 | K141474 | BECTON DICKINSON INTELLIPORT SYSTEM Becton, Dickinson & CO | PHC |
| May 20, 2014 | K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| May 20, 2014 | K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| May 14, 2014 | K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR Becton, Dickinson & CO | ONB |
| Nov 15, 2013 | K133140 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV Becton, Dickinson & CO | GQG |
| Nov 13, 2013 | K133138 | BD Veritor System Flu A+B Assay Becton, Dickinson & CO | PSZ |
| Aug 23, 2013 | K130268 | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | OUY |
| Aug 2, 2013 | K131301 | BD FACS SAMPLE PREP ASSISTANT III Becton, Dickinson & CO | PER |
| Jul 16, 2013 | K131358 | BD PEN NEEDLE Becton, Dickinson & CO | FMI |
| Jul 10, 2013 | K131331 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) Becton, Dickinson & CO | LON |
| Jun 27, 2013 | K123404 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) Becton, Dickinson & CO | LON |
| May 13, 2013 | K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) Becton, Dickinson & CO | MDB |
| Mar 20, 2013 | K121655 | BD ALCOHOL SWAB Becton, Dickinson & CO | LKB |
| Feb 7, 2013 | K121050 | 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE Becton, Dickinson & CO | NGT |
| Jan 18, 2013 | K123300 | BD PEN NEEDLE Becton, Dickinson & CO | FMI |
| Jan 9, 2013 | K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE Becton, Dickinson & CO | ONB |
| Feb 16, 2012 | K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT Becton, Dickinson & CO | NJR |
| Nov 28, 2011 | K113241 | BD EMERALD SINGLE USE, HYPODERMIC SYRINGE Becton Dickinson | FMF |
| Jul 19, 2011 | K110443 | BD INSYTE AUTOGUARD BC Becton, Dickinson & CO | FOZ |
| Mar 18, 2011 | K103798 | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS Becton, Dickinson & CO | OQO |
| Mar 7, 2011 | K102064 | BD FACS SAMPLE PREP ASSISTANT III (SPA III) Becton, Dickinson & CO | GKZ |
| Aug 20, 2010 | K092767 | BBL CHROMAGAR MRSA II Becton, Dickinson & CO | JSO |
| Jul 9, 2010 | K101514 | BD DIRECTIGEN EZ RSV Becton, Dickinson & CO | GQG |
| Jun 29, 2010 | K101502 | BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 Becton, Dickinson & CO | JKA |
| Jun 14, 2010 | K101529 | BD DIRECTIGEN EZ FLU A+B ASSAY Becton, Dickinson & CO | PSZ |
| Feb 19, 2010 | K100209 | BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY Becton, Dickinson & CO | FMI |
| Jan 21, 2010 | K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 Becton, Dickinson & CO | JKA |
| Nov 13, 2009 | K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Nov 13, 2009 | K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| Jul 2, 2009 | K091377 | BD FLU+ SYRINGE Becton, Dickinson & CO | FMF |
| Jul 1, 2009 | K091670 | BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER Becton, Dickinson & CO | LJS |
| Jun 10, 2009 | K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE Becton, Dickinson & CO | NZW |
| Jun 5, 2009 | K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Jun 2, 2009 | K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| May 27, 2009 | K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Jan 29, 2009 | K082852 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML Becton, Dickinson & CO | LON |
| Dec 24, 2008 | K083572 | BD BACTEC Plus Aerobic/F Culture Vials Becton, Dickinson & CO | MDB |
| Dec 11, 2008 | K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Dec 11, 2008 | K081824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| Dec 5, 2008 | K082913 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML Becton, Dickinson & CO | LON |
| Nov 20, 2008 | K082538 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST Becton, Dickinson & CO | LON |
| Oct 6, 2008 | K082271 | FLUCONAZOLE 25UG BBL SENSI-DISC Becton, Dickinson & CO | JTN |
Newest 50 of 199.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-306. Catalog Number: 449292. Open, Classified |
LON | K181665 |
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-312. Catalog Number: 449082. Open, Classified |
LON | K181665 |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735. Open, Classified |
CAZ | None listed |
| May 29, 2026 | Becton Dickinson & Company BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609. Open, Classified |
CAZ | None listed |
| Apr 29, 2026 | Becton Dickinson & Co. BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use Open, Classified |
KZJ | None listed |
| Apr 29, 2026 | Becton Dickinson & Co. BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use Open, Classified |
KZJ | None listed |
| Mar 6, 2026 | Becton Dickinson & Company 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. Open, Classified |
FMF | K980987 |
| Nov 14, 2025 | Becton Dickinson & Company BD Luer Tip Caps;
Catalog Number(s) or Model Number(s): 308341; Open, Classified |
KYW | None listed |
| Nov 7, 2025 | Becton Dickinson & Co. BD Kiestra" Isolate Suspension Cuvette Array;
Catalog No.: 246100; Open, Classified |
LIB | None listed |
| Oct 23, 2025 | Becton Dickinson & Co. BD Veritor Connect Software, labeled as the following:
1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys. Open, Classified |
JJQ | None listed |
| Oct 23, 2025 | Becton Dickinson & Co. BD Phoenix M50 Instrument, labeled as the following:
1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409. Open, Classified |
LON | K020321 K040099 +1 |
| Oct 23, 2025 | Becton Dickinson & Co. BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:
1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927. Open, Classified |
OZN | K111860 K120138 +1 |
| Oct 23, 2025 | Becton Dickinson & Co. BD BACTEC Blood Culture System, labeled as the following:
1. BACTEC 9120 System, Catalog Numbers: 445570, 445702.
2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008. Open, Classified |
MDB | K922475 |
| Oct 23, 2025 | Becton Dickinson & Co. BD BACTEC Blood Culture System, labeled as the following:
1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509.
2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676.
3 Open, Classified |
MDB | K915796 |
| Oct 23, 2025 | Becton Dickinson & Co. BD EpiCenter Microbiology Data Management System, labeled as the following:
1. Computer System Epicenter F/G, Catalog Number: 441002.
2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421.
3 Open, Classified |
JQP | None listed |
| Jul 23, 2025 | Becton Dickinson & Co. BD COR System Software. Model Number: 444829. Open, Classified |
MAQ | None listed |
| Jun 25, 2025 | Becton Dickinson & Co. BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). Open, Classified |
MJA | K021582 |
| Mar 6, 2025 | Becton Dickinson & Co. BD BBL TB Stain Kit K, Catalog (REF): 212522 Open, Classified |
JTS | None listed |
| Jan 21, 2025 | Becton Dickinson & Co. BD PCR Cartridges used with MAX System. Model Number: 437519 Open, Classified |
NJR | K111860 |
| Dec 5, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of c Open, Classified |
JTN | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BACTEC 9240 System
Version or Model: 445475
Catalog Number: 445475 Open, Classified |
MDB | K915796 |
| Dec 3, 2024 | Becton Dickinson & Co. BACTEC 9120 System
Version or Model: 445570
Catalog Number: 445570 Open, Classified |
MDB | K922475 |
| Dec 3, 2024 | Becton Dickinson & Co. BD BACTEC FX40 Instrument
Version or Model: 442296
Catalog Number: 442296 Open, Classified |
MDB | K915796 |
| Dec 3, 2024 | Becton Dickinson & Co. BD BACTEC FX, Instrument Top, Packaged
Version or Model: 441385
Catalog Number: 441385 Open, Classified |
MDB | K915796 |
| Dec 3, 2024 | Becton Dickinson & Co. BD Phoenix M50 Automated Microbiology System
Version or Model: 443624
Catalog Number: 443624 Open, Classified |
LON | K020321 K040099 +1 |
| Dec 3, 2024 | Becton Dickinson & Co. BD Synapsys Informatics Solution (Laboratory Solution)
Version or Model: 444150
Catalog Number: 444150 Open, Classified |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD MAX System, BD MAX Instrument
Version or Model: 441916
Catalog Number: 441916 Open, Classified |
OZN | K111860 K120138 +1 |
| Dec 3, 2024 | Becton Dickinson & Co. BD COR GX Instrument
Version or Model: 443990
Catalog Number: 443990 Open, Classified |
QEP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD COR MX Instrument
Version or Model: 443989
Catalog Number: 443989 Open, Classified |
QEP | K210585 |
| Dec 3, 2024 | Becton Dickinson & Co. BD COR PX Instrument
Version or Model: 443988
Catalog Number: 443988 Open, Classified |
MAQ | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD EpiCenter Data Management System, Multi User Software
Version or Model: 440981
Catalog Number: 440981 Open, Classified |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD EpiCenter Data Management System
Version or Model: 440887
Catalog Number: 440887 Open, Classified |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD EpiCenter Single User Software
Version or Model: 441007
Catalog Number: 441007 Open, Classified |
JQP | None listed |
| Oct 8, 2024 | Becton Dickinson & Co. BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-
IVD standalone laboratory software solution providing data management and workflow management functionality ac Open, Classified |
JQP | None listed |
| Sep 24, 2024 | Becton Dickinson & Co. BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerob Open, Classified |
LON | K020321 K040099 +1 |
| Sep 24, 2024 | Becton Dickinson & Co. BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results fo Open, Classified |
LON | K020321 K040099 +1 |
| Aug 16, 2024 | Becton Dickinson & Co. BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA)
Catalog Number: 245128 Open, Classified |
MJA | K021582 |
| Aug 14, 2024 | Becton Dickinson & Co. BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900; Open, Classified |
KZB | None listed |
| Jun 5, 2024 | Becton Dickinson & Co. BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens. Open, Classified |
QJR | None listed |
| Mar 29, 2024 | Becton Dickinson & Co. BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical Open, Classified |
LON | None listed |
| Mar 29, 2024 | Becton Dickinson & Co. BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical Open, Classified |
LON | K132674 |
| Feb 8, 2024 | Becton Dickinson & Co. BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344 Open, Classified |
JTN | None listed |
Newest 50 of 499.