Data / Medical devices / United States / Cordis US Corp.
Cordis US Corp.: FDA-registered device maker in Santa Clara, CA, United States, 1 PMA approval
Cordis US Corp. is registered with the FDA (registration 3004939290) in Santa Clara, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated August 17, 2005. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004939290
- FEI number
- 3010142363
- Address
- 5452 Betsy Ross Dr, Santa Clara, CA, United States, 95054
- Owner or operator
- Cordis US Corp. (9056360)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 7, 2007
- Registered through
- 2027
- Brand names listed
- MYNX CONTROL VENOUS Vascular Closure Device 6F-12F, Mynx Control Vascular Closure Device, MynxGrip Vascular Closure Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Hemostasis, Vascular | MGB | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 17, 2005 | P040044 | MATRIX VASCULAR CLOSURE SYSTEM (VSG) | MGB | 107 | May 14, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 6, 2016 | 75376 | Class II | Terminated | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a deviation from the firm's standard catheterization technique. | accessdata.fda.gov |
| July 13, 2016 | 74599 | Class II | Terminated | 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times t | A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations. | accessdata.fda.gov |
Compare with other makers
Updated May 14, 2026. 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.