Home › Device types › FLG
Cleaner, Ultrasonic, Medical Instrument
FDA product code FLG · Class 1 · General Hospital
1,302
Registered devices
235
Adverse events
7
Recalls
19
510(k) clearances
Devices with this code
BrandMax Tri-Clean — BRANDMAX INC.BioSonic — COLTENE/WHALEDENT INCBedside Cleaning Sponge — Yangzhou Fartley Medical Instrument Technology Co., LtdENDOZIME AW PLUS (16.9oz/500ml bottle) — Ruhof CorporationProportion® Tartar & Stain Remover — DENTSPLY INTERNATIONAL INC.SCOPEZIME (BLUE) (8.45oz/250ml bottle) — Ruhof CorporationSpec Clean Enzymatic Tablets — MicroCare, LLCLIQUICLEAN-H (30 Gallon/120 Liter Drum) — Ruhof CorporationENDOZIME AW PLUS w/APA NP (4 Liter RB38) — Ruhof CorporationPREPZYME (4 Liter RB38) — Ruhof CorporationProCare Dent 30 C — Chemische Fabrik Dr. Weigert GmbH & Co. KGSanizyme — HEALTHMARK INDUSTRIES CO., INC.CLEANZIME (4 Liter RB38) — Ruhof CorporationBrandMax Tri-Clean — BRANDMAX INC.SURGISTAIN (16.9oz/500ml bottle) — Ruhof CorporationISOGON (HARD WATER)(5GL/20L SP) — Ruhof CorporationENDOZIME PREMIUM w/APA (4 Liter RB38 ) — Ruhof CorporationPREMIXSLIP AW CLEAR (1 Gallon RB38) — Ruhof CorporationSteelco — STEELCO SPAEndocept — WHITELEY CORPORATION PTY LTDPower Cleaner — CETYLITE INDUSTRIES INCRUHOF-PREPZYME NP (22 ounce/650ml bottle) — Ruhof CorporationBioSonic — COLTENE/WHALEDENT INCENDOZIME SLR (1 Gallon RB38) — Ruhof Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-31 | Ultra Clean Systems, Inc. | During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. |
| 2024-08-23 | Young Dental Manufacturing I, LLC | The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. |
| 2020-11-19 | Steris Corporation | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause t |
| 2020-06-26 | Steris Corporation | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. |
| 2007-07-03 | Pacific Bioscience Lab, Inc. | Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns. |
| 2006-06-22 | Steris Corporation | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness |
| 2006-06-22 | Steris Corporation | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness |
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