ABBOTT LABORATORIES

Entity profile compiled from public source records

Public Record Profile Registrations: 66 510(k) filings: 4 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000125596, 1000139754, 1000519796, 1218444, 1221359, 1415939, 1627487, 1628664, 2017865, 2020952, 2024168, 2182269, 2245578, 2648612, 2916596, 2919069, 3001883144, 3002803444, 3002809144, 3003045237, 3003306248, 3003500908, 3003789989, 3004032053, 3004091615, 3004635528, 3004742232, 3004936110, 3005070406, 3005094123, 3005128563, 3005248192, 3005333358, 3005334138, 3005641941, 3005643513, 3005718570, 3005737652, 3006412379, 3006705815, 3007031103, 3007113487, 3008344661, 3008377825, 3008452825, 3008792657, 3008814558, 3009564766, 3009600098, 3011706799, 3012179728, 3012552532, 3013288201, 3014918977, 3015883679, 3016244760, 3016438761, 3016525500, 3017662853, 3019837962, 3020950818, 3023268435, 3029059580, 3033394445, 3038966633
Owner Operator Numbers 1415939
Locations Covered - Central Singapore, SG; ALAMEDA, CA, US; Abbott Park, IL, US; Arecibo, PR, US; Atlanta, GA, US; BURLINGTON, MA, US; Barceloneta, PR, US; Belo Horizonte Minas Gerais, BR; BruCargo Vlaams Brabant, BE; CLONMEL Tipperary, IE; Caguas, PR, US; Cuautitlan Izcalli Mexico, MX; Des Plaines, IL, US; Donegal Town, IE; El Coyol Alajuela, CR; Hamburg, DE; Hangzhou Zhejiang, CN; Heerlen Limburg, NL; Houston, TX, US; IRVINE, CA, US; IRVING, TX, US; Irving, TX, US; Itasca, IL, US; Kilkenny, IE; Lake Forest, IL, US; Longford, IE; Menlo Park, CA, US; Milan Lombardy, IT; Milpitas, CA, US; Minnetonka, MN, US; Oslo, NO; Ottawa Ontario, CA; PLANO, TX, US; PLEASANTON, CA, US; Penang Pulau Pinang, MY; Plymouth, MN, US; Pomona, CA, US; Portland, ME, US; Princeton, NJ, US; Roseville, MN, US; SANTA CLARA, CA, US; SLIGO, IE; Saint Paul, MN, US; San Diego, CA, US; San Ramon, CA, US; Santa Rosa Jauregui Queretaro, MX; Scarborough, ME, US; Shanghai, CN; Sunnyvale, CA, US; Sylmar, CA, US; Temecula, CA, US; WITNEY OXON Oxfordshire, GB; Westbrook, ME, US; Westfield, IN, US; Westford, MA, US; Wiesbaden Hesse, DE; Yongin-si Gyeonggi, KR; ZURICH, CH

Registered Establishments (66)

Registration # Establishment Name Location Establishment Type(s) Action
1218444 THORATEC CORP BURLINGTON, MA, US Complaint File Establishment per 21 CFR 820.198 View Details
1221359 Abbott Diagnostics Scarborough, Inc. Scarborough, ME, US Manufacture Device in the United States for Export Only View Details
1415939 ABBOTT LABORATORIES Abbott Park, IL, US Manufacture Device in the United States for Export Only View Details
1627487 Abbott Medical PLANO, TX, US Manufacture Medical Device View Details
1628664 ABBOTT LABORATORIES IRVING, TX, US Manufacture Medical Device View Details
2017865 ABBOTT MEDICAL Sylmar, CA, US Manufacture Medical Device View Details
2020952 Alere San Diego, Inc. Pomona, CA, US Manufacture Device in the United States for Export Only View Details
2024168 ABBOTT VASCULAR Temecula, CA, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2027969 Alere San Diego, Inc. San Diego, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2030404 IRVINE BIOMEDICAL. INC. IRVINE, CA, US Manufacture Device in the United States for Export Only View Details
2032598 Ameditech, Inc. San Diego, CA, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2135147 Abbott Medical Plymouth, MN, US Complaint File Establishment per 21 CFR 820.198 View Details
2182269 St. Jude Medical, Atrial Fibrillation Division, Inc. Minnetonka, MN, US Manufacture Medical Device View Details
2184149 St. Jude Medical, Atrial Fibrillation Division, Inc. Saint Paul, MN, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
2245578 ABBOTT POINT OF CARE INC. Princeton, NJ, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
2648612 Abbott Medical Caguas, PR, US Manufacture Medical Device View Details
2916596 THORATEC CORP. PLEASANTON, CA, US Manufacture Medical Device View Details
2919069 ABBOTT LABORATORIES Sunnyvale, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2939561 ABBOTT VASCULAR SANTA CLARA, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2954323 ABBOTT DIABETES CARE INC. ALAMEDA, CA, US Complaint File Establishment per 21 CFR 820.198 View Details
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR Manufacture Medical Device View Details
3002809144 ABBOTT GmbH Wiesbaden Hesse, DE Manufacture Medical Device View Details
3003306248 Thoratec Switzerland GMBH ZURICH, CH Manufacture Medical Device View Details
3004032053 Abbott S.r.l. Milan Lombardy, IT Manufacture Medical Device View Details
3004091615 Abbott Vascular Netherlands Heerlen Limburg, NL Export Device to the United States But Perform No Other Operation on Device View Details
3004742232 Cardiovascular Systems Incorporated Saint Paul, MN, US Manufacture Medical Device View Details
3004936110 Abbott Medical Atlanta, GA, US Manufacture Medical Device View Details
3005070406 Abbott Vascular Menlo Park, CA, US Manufacture Device in the United States for Export Only View Details
3005094123 ABBOTT IRELAND DIAGNOSTICS DIVISION Longford, IE Manufacture Medical Device View Details
3005128563 Abbott Diagnostics (Shanghai) Co., Ltd. Shanghai, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3005248192 ABBOTT MOLECULAR, INC. Des Plaines, IL, US Manufacture Device in the United States for Export Only View Details
3005333358 ABBOTT LABORATORIES Lake Forest, IL, US Complaint File Establishment per 21 CFR 820.198 View Details
3005334138 St. Jude Medical, Cardiology Division, Inc. Plymouth, MN, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3005641941 ABON BIOPHARM (HANGZHOU) CO., LTD. Hangzhou Zhejiang, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3005643513 ABBOTT POINT OF CARE CANADA LIMITED Ottawa Ontario, CA Manufacture Medical Device View Details
3005718570 ABBOTT VASCULAR CLONMEL Tipperary, IE Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device View Details
3005737652 ABBOTT VASCULAR Barceloneta, PR, US Manufacture Medical Device View Details
3006412379 Abbott Laboratories (Singapore) Private Limited - Central Singapore, SG Export Device to the United States But Perform No Other Operation on Device View Details
3006705815 Abbott Medical Arecibo, PR, US Manufacture Medical Device View Details
3007031103 Abbott Ireland Diabetes Care Donegal Town, IE Manufacture Medical Device View Details
3007113487 Abbott Medical Saint Paul, MN, US Develop Specifications But Do Not Manufacture At This Facility View Details
3008344661 ABBOTT IRELAND SLIGO, IE Repack or Relabel Medical Device View Details
3008452825 Abbott Medical Costa Rica Ltda. El Coyol Alajuela, CR Manufacture Medical Device View Details
3008494315 Abbott Medical Penang Pulau Pinang, MY Manufacture Medical Device View Details
3008792657 Thoratec Corporation San Ramon, CA, US Manufacture Medical Device View Details
3008814558 CARDIOVASCULAR SYSTEMS INCORPORATED Houston, TX, US Manufacture Medical Device View Details
3009564766 Abbott Vascular El Coyol Alajuela, CR Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device View Details
3009600098 Abbott Medical Westford, MA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3011706799 Abbott Medical Atlanta, GA, US Manufacture Medical Device View Details
3012179728 St. Jude Medical Roseville, MN, US Manufacture Medical Device View Details
3012552532 St. Jude Medical Coordination Center BVBA European Distribution Center BruCargo Vlaams Brabant, BE Export Device to the United States But Perform No Other Operation on Device View Details
3013288201 ABBOTT MEDICAL Minnetonka, MN, US Manufacture Medical Device View Details
3014918977 Abbott Medical Costa Rica Limitada (Structural Heart) El Coyol Alajuela, CR Manufacture Medical Device View Details
3015883679 Abbott Diagnostics Korea Inc. Yongin-si Gyeonggi, KR Manufacture Medical Device View Details
3016244760 Abbott Laboratories de Mexico Cuautitlan Izcalli Mexico, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3016438761 ABBOTT LABORATORIES Irving, TX, US Develop Specifications But Do Not Manufacture At This Facility View Details
3016525500 BIGFOOT BIOMEDICAL, INC. Milpitas, CA, US Repack or Relabel Medical Device View Details
3017662853 Abbott Diagnostics Scarborough, Inc. Westbrook, ME, US Manufacture Device in the United States for Export Only View Details
3019837962 Abbott Molecular Distribution Center Itasca, IL, US Manufacture Device in the United States for Export Only View Details
3020950818 Abbott Medical Westfield, IN, US Manufacture Device in the United States for Export Only View Details
3023268435 Abbott Automation Solutions GmbH Hamburg, DE Manufacture Medical Device View Details
3029059580 Abbott Diagnostics Scarborough, Inc. Portland, ME, US Repack or Relabel Medical Device,Manufacture Medical Device View Details
3033394445 Abbott Ireland, ADC Kilkenny Kilkenny, IE Manufacture Medical Device View Details
3038966633 Abbott Medical Mexico, S. de R.L. de C.V. Santa Rosa Jauregui Queretaro, MX Manufacture Medical Device View Details
9613069 Abbott Diagnostics Technologies AS Oslo, NO Manufacture Medical Device View Details
9710492 ABBOTT DIABETES CARE LIMITED WITNEY OXON Oxfordshire, GB Manufacture Medical Device View Details

510(k) Premarket Notifications (4)

Submission # Device Name Decision Date Decision Description Action
K222850 HAVAb IgG II 2023-08-10 Substantially Equivalent View Details
K832406 QUANTUM II YEAST IDENT. SYSTEM 1983-09-26 Substantially Equivalent View Details
K913718 PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30 Substantially Equivalent View Details
K954575 AXSYM TOXO IGG ANTIBODY ASSAY 1996-08-16 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

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