Inter-Med Llc
FDA Regulatory Profile
Inter-Med Llc appears in FDA public data with 8 recalls, 12 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2400-2026, Class II) was initiated on May 27, 2026. Its most recent 510(k) clearance was granted on April 15, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2400-2026 | Class II | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 | May 27, 2026 |
| Z-0016-2020 | Class II | Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 | June 27, 2019 |
| Z-0017-2020 | Class II | Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 | June 27, 2019 |
| Z-0012-2020 | Class II | Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 | June 27, 2019 |
| Z-0013-2020 | Class II | Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315 | June 27, 2019 |
| Z-0011-2020 | Class II | Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + | June 27, 2019 |
| Z-0015-2020 | Class II | Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355 | June 27, 2019 |
| Z-0014-2020 | Class II | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 | June 27, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253337 | REGEN Bioactive Cement | April 15, 2026 |
| K241489 | ReminGel | January 8, 2025 |
| K241457 | Vista BC Putty | August 28, 2024 |
| K241354 | Sealer Solvent | August 27, 2024 |
| K221811 | Vista BC Sealer | November 21, 2022 |
| K211721 | PS System | December 2, 2021 |
| K112250 | CHX=CHX PLUS | October 28, 2011 |
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS | April 3, 2009 |
| K871291 | AM CATH ESWL STENT | April 30, 1987 |
| K864669 | AM CATH ESWL STENT | January 5, 1987 |
| K851922 | URETERAL STONE DISLODGER | August 2, 1985 |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | January 31, 1984 |