Entity profile compiled from public source records
| Registration # | Establishment Name | Location | Establishment Type(s) | Action |
|---|---|---|---|---|
| 1043534 | WRIGHT MEDICAL TECHNOLOGY, INC. | Arlington, TN, US | Manufacture Medical Device | View Details |
| 1056128 | Stryker Sustainability Solutions Lakeland | LAKELAND, FL, US | Reprocess Single-Use Device | View Details |
| 1649390 | TORNIER, INC. | Bloomington, MN, US | Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198 | View Details |
| 1811755 | STRYKER CORP. | KALAMAZOO, MI, US | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 1831750 | STRYKER MEDICAL | Portage, MI, US | Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 | View Details |
| 2031049 | TMJ Solutions, LLC | San Buenaventura, CA, US | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 2031963 | STRYKER Communications, Inc. | Flower Mound, TX, US | Manufacture Medical Device | View Details |
| 2090040 | Stryker Sustainability Solutions Phoenix | Phoenix, AZ, US | Sterilize Medical Device for Another Party (Contract Sterilizer) | View Details |
| 2249697 | HOWMEDICA OSTEONICS CORP | MAHWAH, NJ, US | Manufacture Medical Device | View Details |
| 2648666 | STRYKER PUERTO RICO, LLC. | ARROYO, PR, US | Repack or Relabel Medical Device,Manufacture Medical Device | View Details |
| 2936485 | STRYKER ENDOSCOPY | SAN JOSE, CA, US | Complaint File Establishment per 21 CFR 820.198 | View Details |
| 3000931034 | Tornier S.A.S. | Montbonnot Saint-Martin Isere, FR | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3003897776 | BIOMIMETIC THERAPEUTICS,LLC | FRANKLIN, TN, US | Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device | View Details |
| 3003902387 | TORNIER, SAS | GRENOBLE CEDEX 1 Isere, FR | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3004123209 | HEARTSINE TECHNOLOGIES, LTD | BELFAST Northern Ireland, GB | Manufacture Medical Device | View Details |
| 3004983210 | TORNIER Inc. | Columbia City, IN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3005445717 | JOLIFE AB | LUND Skane, SE | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3005596372 | CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. | CHANGZHOU, JIANGSU, CN | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3005920920 | HYPERBRANCH MEDICAL TECHNOLOGY INC | Durham, NC, US | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3006345872 | Entellus Medical, Inc | Plymouth, MN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3007456622 | NICO CORPORATION | Indianapolis, IN, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3007495879 | THERMEDX, LLC | Solon, OH, US | Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device | View Details |
| 3007913880 | Stryker (Suzhou) Medical Technology Co.,Ltd. | Suzhou Jiangsu, CN | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3007997036 | STRYKER MANUFACTURING KALAMAZOO | Portage, MI, US | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3008337808 | Stryker Macroom | Co Cork Munster, IE | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3008388276 | TORNIER S.A.S | Montbonnot Saint-Martin Isere, FR | Manufacture Medical Device | View Details |
| 3008668801 | SERF | DECINES CHARPIEU Rhone, FR | Manufacture Medical Device | View Details |
| 3008837339 | STRYKER EMEA Supply Chain Services | Venlo Limburg, NL | Export Device to the United States But Perform No Other Operation on Device | View Details |
| 3008853977 | Stryker Neurovascular | Fremont, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3008881809 | Stryker Neurovascular | Cork Munster, IE | Manufacture Medical Device | View Details |
| 3009350690 | Stryker Sustainability Solutions | Tempe, AZ, US | Reprocess Single-Use Device,Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3010151377 | MOBIUS IMAGING, LLC | Shirley, MA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3010411911 | POM Medical, LLC | Moorpark, CA, US | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3010667733 | WRIGHT MEDICAL TECHNOLOGY, INC. | Memphis, TN, US | Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 | View Details |
| 3010673515 | INTERNATIONAL LIFE SCIENCES | Sandy Springs, GA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3012103978 | Stryker Endoscopy | Greenwood Village, CO, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3012345110 | Novadaq Technologies ULC | Burnaby British Columbia, CA | Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device | View Details |
| 3012497308 | Stryker US Supply Chain Operations | Plainfield, IN, US | Repack or Relabel Medical Device | View Details |
| 3012931345 | Stryker Neurovascular | Salt Lake City, UT, US | Manufacture Medical Device | View Details |
| 3013014058 | Stryker Anngrove | Cork Munster, IE | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3014027736 | IMASCAP | PLOUZANE Finistere, FR | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3015439135 | Stryker Endoscopy | Toronto Ontario, CA | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3015876 | PHYSIO-CONTROL, INC. | Redmond, WA, US | Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device | View Details |
| 3015967359 | Stryker Instruments | Portage, MI, US | Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 | View Details |
| 3016573902 | Ortho-Space Ltd. | Caesarea Haifa, IL | Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198 | View Details |
| 3017410889 | MAKO SURGICAL CORP. | Weston, FL, US | Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3020163307 | Stryker Tijuana Operations | Tijuana Baja California, MX | Reprocess Single-Use Device | View Details |
| 3020347218 | Inari Medical, Inc. | Irvine, CA, US | Manufacture Medical Device | View Details |
| 3023527320 | LimFlow Inc. | Irvine, CA, US | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3030153385 | Stryker Sustainability Solutions - Chandler | Chandler, AZ, US | Reprocess Single-Use Device | View Details |
| 3031800723 | Stryker Poland Manufacturing Sp. z o.o. | Skawina Malopolskie, PL | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 3033273526 | Artelon | ATL, GA, US | Manufacture Medical Device | View Details |
| 3040335671 | Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork (County), IE | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 3040801290 | Inari Medical, Costa Rica S.A. | Grecia Alajuela, CR | Manufacture Medical Device | View Details |
| 8010153 | BERCHTOLD GMBH & CO. KG | TUTTLINGEN Baden-Wurttemberg, DE | Develop Specifications But Do Not Manufacture At This Facility | View Details |
| 8010177 | STRYKER LEIBINGER GMBH & CO. KG | FREIBURG Baden-Wurttemberg, DE | Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 | View Details |
| 8031020 | STRYKER GmbH | SELZACH Solothurn, CH | Manufacture Medical Device | View Details |
| 9610622 | STRYKER TRAUMA GMBH | SCHOENKIRCHEN Schleswig-Holstein, DE | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| 9610726 | HOWMEDICA INTERNATIONAL S. DE R.L., | LIMERICK Munster, IE | Manufacture Medical Device | View Details |
| 9616680 | STRYKER IRELAND OSTEONICS | Cork Munster, IE | Manufacture Medical Device | View Details |
| 9616696 | STRYKER IRELAND LTD., INSTRUMENTS DIVISION | CARRIGTWOHILL, CO.CORK Munster, IE | Manufacture Medical Device for Another Party (Contract Manufacturer) | View Details |
| Submission # | Device Name | Decision Date | Decision Description | Action |
|---|---|---|---|---|
| K881350 | CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM | 1988-09-30 | 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.