Cenorin, LLC
FDA Regulatory Profile
Cenorin, LLC appears in FDA public data with 6 recalls, 1 510(k) clearance, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2288-2018, Class II) was initiated on April 9, 2018. Its most recent 510(k) clearance was granted on September 9, 2019.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2288-2018 | Class II | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610H | April 9, 2018 |
| Z-3033-2017 | Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 | June 7, 2017 |
| Z-3032-2017 | Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 | June 7, 2017 |
| Z-3034-2017 | Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1 | June 7, 2017 |
| Z-1729-2014 | Class II | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when fille | April 24, 2014 |
| Z-1995-2014 | Class II | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | January 24, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Le | September 9, 2019 |