Panels › General Hospital › Product code LDS · Class 2
Device, Pasteurization, Hot Water
Regulation 880.6991
0510(k)s in 12 months (11 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in LDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Cenorin, LLC | 1 | 10 |
| Castle Co. | 2 | 0 |
| Olympic Medical Corp. | 2 | 0 |
| Getinge Disinfection, Inc. | 1 | 0 |
| The Hilrad Co. | 1 | 0 |
| Miele, Inc. | 1 | 0 |
| Miele Appliances, Inc. | 1 | 0 |
| Miele Professional | 1 | 0 |
| Natus Medical Incorporated | 0 | 1 |
| STERIS Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2018 | Cenorin, LLC HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V
Product Usage:
Clean and thermally disinfect medical devices using full Terminated |
LDS | None listed |
| Jun 1, 2016 | Natus Medical Incorporated Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01. Terminated |
LDS | None listed |
| Jul 6, 2014 | Cenorin, LLC HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. Terminated |
LDS | None listed |
| Jun 6, 2014 | Cenorin, LLC HLD Systems Model 610 Washer/High Level Disinfector.
Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Dept Terminated |
LDS | None listed |
| Oct 12, 2010 | Cenorin The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.39 Terminated |
LDS | None listed |
| Oct 12, 2010 | Cenorin The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). The Model 540HT has an external heater (aka High Throughput Heater). This external heater Terminated |
LDS | None listed |
| Oct 12, 2010 | Cenorin HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater.
Each unit Terminated |
LDS | None listed |
| Oct 12, 2010 | Cenorin HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is Terminated |
LDS | None listed |
| Apr 4, 2007 | Cenorin ThermaSure Medical Device Drying Cabinet, series 1000 Terminated |
LDS | None listed |
| Apr 4, 2007 | Cenorin ThermaSure Medical Device Drying Cabinet, series 300 Terminated |
LDS | None listed |
| Apr 4, 2007 | Cenorin ThermaSure Medical Device Drying Cabinet, series 130 Terminated |
LDS | None listed |
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