Data / Medical devices / United States / Becton, Dickinson and Company
Becton, Dickinson and Company: FDA-registered device maker in Mebane, NC, United States, 2 510(k) clearances and 1 PMA approval
Becton, Dickinson and Company is registered with the FDA (registration 3008007472) in Mebane, NC, United States. It lists 9 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated April 29, 2005. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008007472
- Address
- 1022 Corporate Park Drive, Mebane, NC, United States, 27302
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Manufacturer
- First device listed
- December 29, 1977
- Registered through
- 2027
- Brand names listed
- 659611_BD Horizon Brilliant Stain Buffer, BD Alcohol Blend Rinse, BD BBL Agar, Grade A, BD BBL BCYE Agar Base, BD BBL BiGGY Agar, BD BBL Bile Esculin Agar, BD BBL Blood Agar Base Infusion Agar, BD BBL Blood Agar Slants and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Filters, Cell Collection, Tissue Processing | KET | 1 | Manufacturer | accessdata.fda.gov |
| Fixative, Alcohol Containing | LDZ | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Processor, Cervical Cytology Slide, Automated | MKQ | 3 | Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Manufacturer | accessdata.fda.gov |
| Stains, Dye Solution | LEE | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2005 | K050745 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 23, 2002 | K020321 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM | LON | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 17, 1999 | P970018 | BD PREPSTAIN SYSTEM | MKQ | 36 | September 6, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 22, 2012 | 61737 | Class III | Terminated | PrepStain Syringing Pipettes 240 (Catalog #490517) | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes | accessdata.fda.gov |
| December 8, 2011 | 62117 | Class II | Terminated | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. | accessdata.fda.gov |
| October 6, 2011 | 61444 | Not yet classified | Terminated | BD Focal Point"100V, Catalog number: 490650 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology s | The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Container, Specimen, Non-Sterile
- All makers of Fixative, Alcohol Containing
- All makers of Slides, Microscope
- All makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- All makers of Processor, Cervical Cytology Slide, Automated
Updated September 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.