BAXTER HEALTHCARE CORPORATION

Entity profile compiled from public source records

Public Record Profile Registrations: 33 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 1000182014, 1000359047, 1019003, 1025114, 1314492, 1316463, 1416980, 1417572, 1824206, 2025695, 2027454, 2183620, 2183816, 2649614, 2937398, 3000230206, 3000302153, 3002806443, 3002806588, 3003184737, 3003704957, 3003888652, 3004450973, 3005004021, 3005468265, 3006087789, 3006697241, 3007143268, 3008145987, 3013836619, 3014226707, 3015158050, 3019252669, 3019257308
Owner Operator Numbers 1417572, 9043836
Locations Covered 1-7052 Cartago, CR; AIBONITO, PR, US; APODACA Nuevo Leon, MX; BIRMINGHAM, AL, US; Bangalore Karnataka, IN; Batesville, IN, US; Bellevue, WA, US; Braine-l'Alleud Wallonia, BE; CLEVELAND, MS, US; ELSTREE Hertfordshire, GB; HAYWARD, CA, US; Haina San Cristobal, DO; Hergiswil Nidwalden, CH; IRVINE, CA, US; LESSINES Hainaut, BE; LIMENA Padova, IT; LULEA Norrbotten, SE; Ladson, SC, US; MARION, NC, US; MEDINA, NY, US; Marsa, MT; Munich Bavaria, DE; PORDENONE, IT; ROUND LAKE, IL, US; Raleigh, NC, US; SAALFELD Thuringia, DE; SAINT PAUL, MN, US; Saint Paul, MN, US; Singapore North East, SG; Skaneateles Falls, NY, US; TIJUANA Baja California, MX; Taicang City Jiangsu, CN; Tel Aviv, IL

Registered Establishments (33)

Registration # Establishment Name Location Establishment Type(s) Action
1000359047 Baxter R&D Europe SPRL Braine-l'Alleud Wallonia, BE Develop Specifications But Do Not Manufacture At This Facility View Details
1019003 BAXTER HEALTHCARE CORPORATION CLEVELAND, MS, US Manufacture Medical Device View Details
1025114 BAXTER HEALTHCARE CORPORATION MARION, NC, US Manufacture Medical Device View Details
1062741 SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) BIRMINGHAM, AL, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
1066635 Hill-Rom Company, Inc. Ladson, SC, US Repack or Relabel Medical Device,Manufacture Medical Device View Details
1314492 Baxter Healthcare Corporation MEDINA, NY, US Manufacture Medical Device View Details
1316463 WELCH ALLYN, INC. Skaneateles Falls, NY, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
1416980 BAXTER HEALTHCARE CORPORATION ROUND LAKE, IL, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
1824206 HILL-ROM, INC. Batesville, IN, US Develop Specifications But Do Not Manufacture At This Facility View Details
2025695 BAXTER HEALTHCARE CORPORATION IRVINE, CA, US Manufacture Device in the United States for Export Only View Details
2027454 HILL-ROM, INC. Raleigh, NC, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2183620 SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) Saint Paul, MN, US Manufacture Medical Device View Details
2183816 HILL-ROM MANUFACTURING, INC. SAINT PAUL, MN, US Repack or Relabel Medical Device,Manufacture Medical Device View Details
2649614 Baxter Healthcare of Puerto Rico LLC AIBONITO, PR, US Manufacture Medical Device View Details
2937398 BAXTER HEALTHCARE CORPORATION HAYWARD, CA, US Manufacture Medical Device View Details
3003704957 Baxter Limited Marsa, MT Develop Specifications But Do Not Manufacture At This Facility View Details
3004450973 APATECH LTD. ELSTREE Hertfordshire, GB Manufacture Medical Device View Details
3005004021 Baxter Healthcare - Tel Aviv Tel Aviv, IL Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device View Details
3006087789 WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. TIJUANA Baja California, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3006697241 HILL-ROM DE MEXICO S DE RL DE CV APODACA Nuevo Leon, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3007143268 Baxter Medical Systems GmbH + Co. KG SAALFELD Thuringia, DE Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3008145987 Hill-Rom Services Private Limited Singapore North East, SG Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 View Details
3013836619 Baxter Medical Systems (Suzhou) Co. Ltd Taicang City Jiangsu, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3014226707 BARDY DIAGNOSTICS, INC. Bellevue, WA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3015158050 Baxter Innovations & Business Solutions Pvt. Ltd. Bangalore Karnataka, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3019252669 VIDEOMED SRL PORDENONE, IT Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3019257308 VIDEOMED SRL LIMENA Padova, IT Develop Specifications But Do Not Manufacture At This Facility View Details
8010130 BAXTER SA LESSINES Hainaut, BE Manufacture Medical Device View Details
8030916 LIKO AB LULEA Norrbotten, SE Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198 View Details
8040700 BAXTER PRODUCTOS MEDICOS, LTDA. 1-7052 Cartago, CR Manufacture Medical Device View Details
9612052 Baxter Healthcare, S.A. Haina San Cristobal, DO Manufacture Medical Device View Details
9612773 Biover AG Hergiswil Nidwalden, CH Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device View Details
9681407 Baxter Medical Systems GmbH + Co. KG Munich Bavaria, DE Develop Specifications But Do Not Manufacture At This Facility View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0030-2020 L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. Reason: Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis. 2018-10-10 Terminated View Details

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