Stryker Imaging
Flower Mound, TX
Stryker Imaging appears in FDA device records in Flower Mound, TX. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0134-2010 | Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. | Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis. | Terminated | ||
| Z-0160-2010 | Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan. | Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis. | Terminated | ||
| Z-0168-2010 | Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan. | Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain