FDA Device Entity Profile: Becton Dickinson and Company

Known Identifiers & Locations

FEI Numbers 1000174591, 1000232458, 1000366600, 1024879, 1025402, 1111096, 1119779, 1211998, 1213809, 1710034, 1911916, 1917413, 1920898, 2243072, 2647876, 2648045, 2649711, 3002601200, 3002682307, 3002806482, 3002806485, 3002879021, 3003081151, 3003152976, 3003910417, 3005698992, 3006948883, 3007420875, 3007886372, 3008007472, 3008352382, 3010141591, 3013055489, 3015292643, 3015983454, 3027394506, 3032916632, 3036495171, 3042941992

Owner Operator Numbers 10093301, 9922032

Locations Covered AMSTERDAM Noord-Holland, NL; ANASCO, PR, US; BROKEN BOW, NE, US; CANAAN, CT, US; CAYEY, PR, US; COLUMBUS, NE, US; CUAUTITLAN, IZCALLI Queretaro, MX; CURITIBA Parana, BR; Cayey, PR, US; China (Jiangsu) Pilot Free Trade Zone Suzhou Area, CN; Cockeysville, MD, US; DROGHEDA Louth, IE; Drachten Fryslan, NL; FRAGA Huesca, ES; FRANKLIN LAKES, NJ, US; GRAYSON, GA, US; HAINA San Cristobal, DO; HEIDELBERG Baden-Wurttemberg, DE; HOLDREGE, NE, US; Irvine, CA, US; JUIZ DE FORA Minas Gerais, BR; Juncos, PR, US; Macquarie Park New South Wales, AU; Mebane, NC, US; Milpitas, CA, US; NOGALES Sonora, MX; Plymouth Devon, GB; Quebec, CA; SAN AGUSTIN DE GUADALIX Madrid (Province), ES; SINGAPORE North West, SG; SPARKS, MD, US; SUMTER, SC, US; San Diego, CA, US; Sandy, UT, US; Suzhou Jiangsu, CN; Temse Oost-Vlaanderen, BE

Registered Establishments (38)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1024879	BECTON, DICKINSON & CO., (BD)	SUMTER, SC, US	Manufacture Medical Device	View Details
1025402	LEE LABORATORIES, INC.	GRAYSON, GA, US	Manufacture Medical Device	View Details
1111096	BECTON, DICKINSON & CO.	Cockeysville, MD, US	Manufacture Medical Device	View Details
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details
1213809	Becton, DIckinson and Company	CANAAN, CT, US	Manufacture Medical Device	View Details
1710034	BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.	Sandy, UT, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
1911916	BECTON DICKINSON AND COMPANY	COLUMBUS, NE, US	Manufacture Medical Device	View Details
1917413	BECTON, DICKINSON & CO.	BROKEN BOW, NE, US	Manufacture Medical Device	View Details
1920898	BD MEDICAL	HOLDREGE, NE, US	Sterilize Medical Device for Another Party (Contract Sterilizer)	View Details
2243072	BECTON DICKINSON	FRANKLIN LAKES, NJ, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
2618282	BD Puerto Rico LLC	Juncos, PR, US	Manufacture Medical Device	View Details
2647876	BECTON DICKINSON CARIBE LTD.	CAYEY, PR, US	Manufacture Medical Device	View Details
2648045	EDWARDS LIFESCIENCES TECHNOLOGY SARL	ANASCO, PR, US	Manufacture Medical Device	View Details
3002601200	Becton Dickinson Medical Devices Co., Ltd. Suzhou	Suzhou Jiangsu, CN	Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3002682307	BECTON DICKINSON, S.A.	FRAGA Huesca, ES	Manufacture Medical Device	View Details
3003152976	BECTON DICKINSON, S.A.	SAN AGUSTIN DE GUADALIX Madrid (Province), ES	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR	Manufacture Medical Device	View Details
3006948883	BD Rapid Diagnostics (Suzhou) Co. Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area, CN	Manufacture Medical Device	View Details
3007420875	GeneOhm Sciences Canada, ULC.	Quebec, CA	Manufacture Medical Device	View Details
3007886372	BECTON, DICKINSON & CO.	San Diego, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3008007472	Becton, Dickinson and Company	Mebane, NC, US	Manufacture Medical Device	View Details
3008352382	Becton Dickinson Caribe, LTD	Cayey, PR, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL	Develop Specifications But Do Not Manufacture At This Facility	View Details
3013055489	BD European Distribution Center	Temse Oost-Vlaanderen, BE	Export Device to the United States But Perform No Other Operation on Device	View Details
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US	Repack or Relabel Medical Device	View Details
3015983454	Becton Dickinson Pty Ltd	Macquarie Park New South Wales, AU	Export Device to the United States But Perform No Other Operation on Device	View Details
3027394506	Becton, Dickinson and Company, BD Biosciences	Milpitas, CA, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3036495171	BD Biosciences San Diego	San Diego, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3042941992	Edwards Lifesciences Holding B.V.	AMSTERDAM Noord-Holland, NL	Develop Specifications But Do Not Manufacture At This Facility	View Details
8041187	BECTON DICKINSON MEDICAL (SINGAPORE)	SINGAPORE North West, SG	Manufacture Medical Device	View Details
9610048	BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.	JUIZ DE FORA Minas Gerais, BR	Manufacture Medical Device	View Details
9610847	BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.	NOGALES Sonora, MX	Manufacture Medical Device	View Details
9614033	BECTON DICKINSON DE MEXICO	CUAUTITLAN, IZCALLI Queretaro, MX	Manufacture Medical Device	View Details
9615817	CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG	HAINA San Cristobal, DO	Manufacture Medical Device	View Details
9616657	BECTON, DICKINSON AND CO.	DROGHEDA Louth, IE	Manufacture Medical Device	View Details
9617032	Becton, Dickinson & Company (BD)	Plymouth Devon, GB	Manufacture Medical Device	View Details
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE	Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K213616	BD Surgiphor Antimicrobial Irrigation System	2022-03-23	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0022-2009	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery. Reason: Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.	2008-09-15	Terminated	View Details

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