Data / Medical devices / Spain / Becton Dickinson, S.A.
Becton Dickinson, S.A.: FDA-registered device maker in SAN AGUSTIN DE GUADALIX Madrid(Province), Spain, 7 510(k) clearances
Becton Dickinson, S.A. is registered with the FDA (registration 3003152976) in SAN AGUSTIN DE GUADALIX Madrid(Province), Spain. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003152976
- Address
- Camino De Valdeolivia, S/N, SAN AGUSTIN DE GUADALIX Madrid(Province), Spain, 28750
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- BD Hypodermic Syringe, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR, BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55, BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle, BD PhaSeal Optima Closed System Drug Transfer Device, BD PhaSeal Optima Closed System Transfer Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 1, 2022 | K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 22, 2021 | K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| September 29, 2020 | K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 14, 2019 | K182589 | BD Plastipak Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 7, 2009 | K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | LHI | Substantially Equivalent | Carmel Pharma Ab. | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Syringe, Piston
- All makers of Device, Intravascular Catheter Securement
- All makers of Set, I.V. Fluid Transfer
- All makers of Stand, Infusion
Updated July 1, 2022. 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.