Panels › General Hospital › Product code FLG · Class 1
Cleaner, Ultrasonic, Medical Instrument
Regulation 880.6150
0510(k)s in 12 months (19 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in FLG
| Company | 510(k)s | Recalls |
|---|---|---|
| Palmetto Chemical & Supply Co., Inc. | 4 | 0 |
| Steris Corporation | 0 | 4 |
| Calgon Corp. | 3 | 0 |
| Calgon Vestal Div. | 3 | 0 |
| Custom Ultrasonics | 1 | 0 |
| Fisons Corp. | 1 | 0 |
| Keymed, Inc. | 1 | 0 |
| Medical Polymers, Inc. | 1 | 0 |
| Nobelpharma USA, Inc. | 1 | 0 |
| Pacific Bioscience Lab, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2025 | Ultra Clean Systems, Inc. Ultrasonic Cleaning Systems
Triton 36 Model Number 6003000804
Triton 72 Model Number 6003000805
Ultrasonic cleaning system Open, Classified |
FLG | None listed |
| Oct 1, 2024 | Young Dental Manufacturing I, LLC BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution. Open, Classified |
FLG | None listed |
| Nov 19, 2020 | Steris Corporation Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial Terminated |
FLG | None listed |
| Jun 26, 2020 | Steris Corporation InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, bl Terminated |
FLG | None listed |
| Nov 16, 2007 | Pacific Bioscience Lab, Inc. Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Belle Terminated |
FLG | None listed |
| Aug 25, 2006 | Steris Corporation Amsco Sonic Energy Console, Part Nos.: B602047470, P080000002, P080000003, B018905015, B018905016, B018905017, B018905018, B018905JAE, B018905JAESS, B018905JAESSI, B018905JAG, B018905JAGSS Terminated |
FLG | None listed |
| Aug 25, 2006 | Steris Corporation Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS Terminated |
FLG | None listed |
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