Inter-Med, Inc.
Medical device manufacturer in Racine, WI.
12510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253337 | REGEN Bioactive CementEMA · Traditional | 04/15/2026SE |
| K241489 | ReminGelLBH · Traditional | 01/08/2025SE |
| K241457 | Vista BC PuttyKIF · Traditional | 08/28/2024SE |
| K241354 | Sealer SolventKJJ · Traditional | 08/27/2024SE |
| K221811 | Vista BC SealerKIF · Traditional | 11/21/2022SE |
| K211721 | PS SystemNYL · Traditional | 12/02/2021SE |
| K112250 | Chx=Chx PlusKJJ · Traditional | 10/28/2011SE |
| K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…KJJ · Traditional | 04/03/2009SE |
| K871291 | Am Cath Eswl StentFAD · Traditional | 04/30/1987SE |
| K864669 | Am Cath Eswl StentFAD · Traditional | 01/05/1987SE |
| K851922 | Ureteral Stone DislodgerFFL · Traditional | 08/02/1985SE |
| K833058 | Gen. Purpose Instrument Trays &FSM · Traditional | 01/31/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2400-2026 Class II | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert… | 05/27/2026Open, Classified |
| Z-0017-2020 Class II | Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0016-2020 Class II | Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0015-2020 Class II | Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0014-2020 Class II | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF…The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0013-2020 Class II | Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0012-2020 Class II | Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0011-2020 Class II | Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL -…The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |