Data / Medical devices / United States / Cardinal Health
Cardinal Health: FDA-registered device maker in Wabasha, MN, United States, 7 510(k) clearances
Cardinal Health is registered with the FDA (registration 2183164) in Wabasha, MN, United States. It lists 11 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 21, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183164
- FEI number
- 1000116809
- Address
- 1313 West Grant BLVD., Wabasha, MN, United States, 55981
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 14, 1994
- Registered through
- 2026
- Brand names listed
- AMPCARE E Series Electrodes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Iontophoresis, Other Uses | EGJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Contract manufacturer | accessdata.fda.gov |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | 3 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | NAM | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 21, 2009 | K083350 | TENS/NMES/FES STIMULATING ELECTRODE | GXY | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| September 17, 1999 | K983097 | TENS/FES/NMES ELECTRODES | GXY | Substantially Equivalent | Uni-Patch, Inc. | accessdata.fda.gov |
| July 31, 1996 | K962332 | TENS/FES/NMES ELECTRODES | GZJ | Substantially Equivalent | Uni-Patch, Inc. | accessdata.fda.gov |
| January 14, 1992 | K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | GXY | Substantially Equivalent | Labeltape Meditect, Inc. | accessdata.fda.gov |
| July 19, 1990 | K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | GXY | Substantially Equivalent | Labeltape Meditect, Inc. | accessdata.fda.gov |
| May 2, 1990 | K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD | GXY | Substantially Equivalent | Pioneering Technologies, Inc. | accessdata.fda.gov |
| September 26, 1985 | K853552 | SENTRY FLEXIBLE TENS | GXY | Substantially Equivalent | Sentry Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 9, 2012 | 61209 | Class II | Terminated | Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES,. Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., t | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Computer, Diagnostic, Programmable
- All makers of Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Updated December 10, 2012. 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.