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Inter-Med Llc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
11
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0016-2020Class IIVista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825June 27, 2019
Z-0013-2020Class IIVista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315June 27, 2019
Z-0015-2020Class IIVista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355June 27, 2019
Z-0017-2020Class IIVista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850June 27, 2019
Z-0012-2020Class IIVista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300June 27, 2019
Z-0011-2020Class IIVista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + June 27, 2019
Z-0014-2020Class IIVista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350June 27, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K241489ReminGelJanuary 8, 2025
K241457Vista BC PuttyAugust 28, 2024
K241354Sealer SolventAugust 27, 2024
K221811Vista BC SealerNovember 21, 2022
K211721PS SystemDecember 2, 2021
K112250CHX=CHX PLUSOctober 28, 2011
K082470SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS April 3, 2009
K871291AM CATH ESWL STENTApril 30, 1987
K864669AM CATH ESWL STENTJanuary 5, 1987
K851922URETERAL STONE DISLODGERAugust 2, 1985
K833058GEN. PURPOSE INSTRUMENT TRAYS &January 31, 1984