Data / Medical devices / United States / Icp Medical (dba: Cordica Medical, Inc.)
Icp Medical (dba: Cordica Medical, Inc.): FDA-registered device maker in Earth City, MO, United States, 1 510(k) clearance
Icp Medical (dba: Cordica Medical, Inc.) is registered with the FDA (registration 1933975) in Earth City, MO, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1933975
- FEI number
- 3001560380
- Address
- 13720 Rider Trail North, Earth City, MO, United States, 63045
- Owner or operator
- Cordica Medical (Formally Team Technologies, Inc) (1051594)
- Roles
- Complaint file establishment
- First device listed
- January 10, 2013
- Registered through
- 2027
- Brand names listed
- Comfort Caps, Personal Protective Shoe Covers, Stretcher Sheets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Surgical | FYF | 1 | Complaint file establishment | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Complaint file establishment | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Complaint file establishment | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Complaint file establishment | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 4, 2016 | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | FYC | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Gown, Examination
- All makers of Shoe And Shoe Cover, Conductive
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Gown, Isolation, Surgical
- All makers of Cap, Surgical
Updated November 4, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.