Entity profile compiled from public source records
| Registration # | Establishment Name | Location | Establishment Type(s) | Action |
|---|---|---|---|---|
| 1000432246 | MEDICREA INTERNATIONAL | RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FR | Manufacture Medical Device | View Details |
| 1030489 | MEDTRONIC SOFAMOR DANEK USA, INC. | Memphis, TN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 1045254 | MEDTRONIC XOMED, INC. | Jacksonville, FL, US | Manufacture Medical Device | View Details |
| 1219071 | MEDTRONIC XOMED, INC. | Mystic, CT, US | Manufacture Medical Device | View Details |
| 1220452 | MEDTRONIC VASCULAR | DANVERS, MA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 1625507 | MEDTRONIC POWERED SURGICAL SOLUTIONS | FORT WORTH, TX, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 1718389 | MEDTRONIC PERFUSION SYSTEMS | PARKER, CO, US | Manufacture Medical Device | View Details |
| 1723170 | MEDTRONIC NAVIGATION, INC. | Lafayette, CO, US | Manufacture Medical Device | View Details |
| 1824199 | WARSAW ORTHOPEDIC, INC. | WARSAW, IN, US | Manufacture Medical Device | View Details |
| 2025587 | Medtronic Heart Valves Division | Santa Ana, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 2029214 | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR | Irvine, CA, US | Manufacture Medical Device | View Details |
| 2182207 | MEDTRONIC NEUROMODULATION | Minneapolis, MN, US | Manufacture Medical Device | View Details |
| 2182208 | MEDTRONIC, INC. | Mounds View, MN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 2183870 | Medtronic, Inc. | Plymouth, MN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 2184009 | MEDTRONIC PERFUSION SYSTEMS | Minneapolis, MN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 2249915 | OSTEOTECH, INC. | EATONTOWN, NJ, US | Manufacture Medical Device | View Details |
| 2647346 | MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO | HUMACAO, PR, US | Manufacture Medical Device | View Details |
| 2649622 | MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA | Villalba, PR, US | Manufacture Medical Device | View Details |
| 2953200 | Medtronic Vascular | Santa Rosa, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3002648230 | Medtronic CryoCath LP | Pointe-Claire Quebec, CA | Manufacture Medical Device | View Details |
| 3002807561 | MEDTRONIC B.V. (EOC) | HEERLEN Limburg, NL | Export Device to the United States But Perform No Other Operation on Device | View Details |
| 3003120897 | MEDTRONIC SOFAMOR DANEK USA, INC. | Memphis, TN, US | Manufacture Medical Device | View Details |
| 3003276151 | Medtronic Bakken Research Center B.V. (BRC) | Maastricht Limburg, NL | Manufacture Medical Device | View Details |
| 3003955307 | Medtronic Grand Rapids | Grand Rapids, MI, US | Manufacture Medical Device | View Details |
| 3004185781 | Medtronic, Inc. | Tempe, AZ, US | Manufacture Medical Device | View Details |
| 3004209178 | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | Juncos, PR, US | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3004497303 | MEDTRONIC MEXICO EG | EMPALME Sonora, MX | Manufacture Medical Device | View Details |
| 3004594267 | Medtronic Care Management Services | Lafayette, CO, US | Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3004785967 | MEDTRONIC NAVIGATION, INC. (Boxborough) | Boxborough, MA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3005075696 | MAZOR ROBOTICS LTD. | Caesarea Haifa, IL | Manufacture Medical Device | View Details |
| 3005677016 | Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, CN | Manufacture Medical Device | View Details |
| 3007042319 | HeartWare, Inc. | Miami Lakes, FL, US | Manufacture Medical Device | View Details |
| 3008301917 | INTERSECT ENT | Menlo Park, CA, US | Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device | View Details |
| 3008592544 | Medtronic, Inc. (Minneapolis, MN 55447) | Minneapolis, MN, US | Manufacture Medical Device | View Details |
| 3008973940 | Medtronic Singapore Operations Pte Ltd | Singapore Central Singapore, SG | Repack or Relabel Medical Device,Manufacture Medical Device | View Details |
| 3009380063 | Medtronic Distribution Center | Memphis, TN, US | Repack or Relabel Medical Device | View Details |
| 3011468686 | MC3, Inc. | Dexter, MI, US | Manufacture Medical Device | View Details |
| 3011577940 | Titan Spine, a Division of Medtronic | Milwaukee, WI, US | Manufacture Medical Device | View Details |
| 3011795235 | MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH | DEGGENDORF Bavaria, DE | Manufacture Medical Device | View Details |
| 3012520654 | MEDTRONIC, INC. | Billerica, MA, US | Manufacture Medical Device | View Details |
| 3013060098 | Medtronic Canada ULC | Milton, ON Ontario, CA | Export Device to the United States But Perform No Other Operation on Device | View Details |
| 3014129161 | CATHWORKS LTD. | Kfar Saba Central, IL | Manufacture Medical Device | View Details |
| 3014725904 | Medtronic Medical Costa Rica S.R.L. | Coyol Alajuela, CR | Manufacture Medical Device | View Details |
| 3015192387 | CATHWORKS | Newport Beach, CA, US | Manufacture Medical Device | View Details |
| 3015531529 | Medtronic Neurosurgery | Fort Worth, TX, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3015544746 | Medtronic, Inc. | Minneapolis, MN, US | Manufacture Medical Device | View Details |
| 3015550451 | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR | Irvine, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3018094310 | Medtronic Engineering and Innovation Center (MEIC) | Hyderabad Telangana, IN | Complaint File Establishment per 21 CFR 820.198 | View Details |
| 9611350 | MEDTRONIC FABRICATION S.A.S. | FOURMIES Nord, FR | Manufacture Medical Device | View Details |
| 9612164 | MEDTRONIC IRELAND | GALWAY, IE | Manufacture Medical Device | View Details |
| 9614453 | Medtronic Europe Sarl | TOLOCHENAZ Vaud, CH | Manufacture Medical Device | View Details |
| 9617601 | Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, MX | Manufacture Medical Device | View Details |
| Submission # | Device Name | Decision Date | Decision Description | Action |
|---|---|---|---|---|
| K103464 | PACIFIC XTREME PTCA BALLOON DILATATION CATHETER | 2010-12-22 | Substantially Equivalent | View Details |
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | 2011-06-08 | Substantially Equivalent | View Details |
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.