Data / Medical devices / United States / Healthmark Industries Co., Inc.
Healthmark Industries Co., Inc.: FDA-registered device maker in Fraser, MI, United States, 2 510(k) clearances
Healthmark Industries Co., Inc. is registered with the FDA (registration 1834190) in Fraser, MI, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 7, 2023. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1834190
- FEI number
- 1000160387
- Address
- 18600 Malyn Blvd., Fraser, MI, United States, 48026
- Owner or operator
- Healthmark (9008981)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 24, 2009
- Registered through
- 2026
- Brand names listed
- Disposable Bulb & Bladder, EndoScope Brushes, Endoscope Soaking Basin, Instru-Trays, Micro Protech Trays, Plastic Sterilizing Baskets, SafeGuard Dry, SafeGuard Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Basin For Endoscope Reprocessing | PHT | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 7, 2023 | K230137 | Reliance® Fusion Sterilization Wraps | FRG | Substantially Equivalent | Ahlstrom-Munksjo Nonwovens, LLC | accessdata.fda.gov |
| June 29, 2017 | K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | FRG | Substantially Equivalent | Ahlstrom Nonwovens, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 7, 2026 | 99943 | Class II | Ongoing | Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE | Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. | accessdata.fda.gov |
| July 29, 2026 | 99537 | Class II | Ongoing | healthmark ProChek-II, Model Number PT-313, PT-201-12 | Test manufactured with an expired ingredient which may present as either a false negative or positive. | accessdata.fda.gov |
| March 12, 2026 | 98627 | Class II | Ongoing | Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style | Product does not have FDA clearance. | accessdata.fda.gov |
| May 2, 2025 | 96823 | Class II | Ongoing | Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 | During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose. | accessdata.fda.gov |
Compare with other makers
- All makers of Basin For Endoscope Reprocessing
- All makers of Tray, Surgical, Instrument
- All makers of Wrap, Sterilization
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Adaptor, Bulbs, Miscellaneous, For Endoscope
- All makers of Cleaner, Ultrasonic, Medical Instrument
Updated October 15, 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.