Company
Healthmark Industries Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (4 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Healthmark Industries Co., Inc. 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 GUA Open, Classified |
MDM | None listed |
| Aug 26, 2026 | Healthmark Industries Co., Inc. healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001 Open, Classified |
SDC | None listed |
| Aug 26, 2026 | Healthmark Industries Co., Inc. healthmark ProChek-II, Model Number PT-313, PT-201-12 Open, Classified |
SDC | None listed |
| Apr 24, 2026 | Healthmark Industries Co., Inc. Mesh Style Tip Protectors
CSW-03-2.0 Open-end style
CSW-04-4.0 Closed-end style Open, Classified |
OCU | None listed |
| Jun 5, 2025 | Healthmark Industries Co., Inc. ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) Open, Classified |
MNL | None listed |
| Jun 5, 2025 | Healthmark Industries Co., Inc. Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 Open, Classified |
MNL | None listed |