Healthmark Industries Co., Inc.
Fraser, MI, US
HEALTHMARK INDUSTRIES CO., INC. appears in FDA device records in Fraser, MI. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1834190 | 1000160387 | HEALTHMARK INDUSTRIES CO., INC. | 18600 Malyn Blvd., Fraser, MI 48026 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3032-2026 | healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001 | Test manufactured with an expired ingredient which may present as either a false negative or positive. | Class II | Open, Classified | |
| Z-3031-2026 | 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. | Class II | Open, Classified | |
| Z-1943-2026 | Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style | Product does not have FDA clearance. | Class II | Open, Classified | |
| Z-1910-2025 | ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) | 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. | Class II | Open, Classified | |
| Z-1909-2025 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain