Home › Device types › FLG
Cleaner, Ultrasonic, Medical Instrument
FDA product code FLG · Class 1 · General Hospital
1,286
Registered devices
232
Adverse events
7
Recalls
19
510(k) clearances
Devices with this code
neodisher Mielclear — Chemische Fabrik Dr. Weigert GmbH & Co. KGSteelco — STEELCO SPAORTHOZIME (30 Gallon/120 Liter Drum) — Ruhof CorporationENDOZIME XP (4 Liter RB53) — Ruhof CorporationPatterson™ Super Concentrated General Purpose Ultrasonic Cleaning Solution — DENTSPLY INTERNATIONAL INC.ENDOZIME (4 Liter RB38) — Ruhof CorporationENDOZIME (60 Liter Drum) — Ruhof CorporationENDOZIME SLR (OLESTRAZIME) SPONGE — Ruhof CorporationENDOZIME AW PLUS w/APA NP (1 Gallon RB38) — Ruhof CorporationProCare Dent 30 C — Chemische Fabrik Dr. Weigert GmbH & Co. KGCleaning Sponge — Yangzhou Fartley Medical Instrument Technology Co., LtdBioSonic — COLTENE/WHALEDENT INCDetonox — ALCONOX INCLIQUIZIME (16.9oz/500ml bottle) — Ruhof CorporationTres Clean — Germiphene CorporationProlystica — STERIS CORPORATIONDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCTergajet — ALCONOX INCProCare Dent 30 P — Chemische Fabrik Dr. Weigert GmbH & Co. KGHenry Schein — HENRY SCHEIN, INC.Henry Schein — HENRY SCHEIN, INC.KARTZIME (1 Gallon RB38) — Ruhof CorporationENDOZIME BIO-CLEAN (10 Liter SB63) — Ruhof CorporationENDOZIME PREMIUM w/APA (1 Liter bottle) — 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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