Data / Medical devices / United States / MAR-MED Inc.
MAR-MED Inc.: FDA-registered device maker in Grand Rapids, MI, United States, 2 510(k) clearances
MAR-MED Inc. is registered with the FDA (registration 1832653) in Grand Rapids, MI, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 4, 1990. 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
- 1832653
- Address
- 333 Fuller Ave NE, Grand Rapids, MI, United States, 49503
- Owner or operator
- Mar-Med Inc (1832653)
- Roles
- Manufacturer
- First device listed
- December 28, 2009
- Registered through
- 2026
- Brand names listed
- Balloon Extractor, Derma-Stent, Klenzalac, SplashShield, Supershield, Tourni-Cot, ZeroWet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Snare, Nasal | KBE | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | 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 |
|---|---|---|---|---|---|---|
| September 4, 1990 | K900208 | ZEROWET SPLASHIELD | KYZ | Substantially Equivalent | Zerowet Splashield | accessdata.fda.gov |
| October 10, 1985 | K853472 | FINGER TOURNIQUETTE | GAX | Substantially Equivalent | Joseph B. Marogil | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 28, 2020 | 87009 | Class II | Terminated | Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field. | A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia. | accessdata.fda.gov |
Compare with other makers
- All makers of Tourniquet, Nonpneumatic
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Snare, Nasal
- All makers of Catheter, Irrigation
Updated February 2, 2021. 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.