Comet Technologies USA Inc
Shelton, CT, US
Comet Technologies Usa Inc appears in FDA device records in Shelton, CT. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 2
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2106-2019 | YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control | Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door. | Class II | Terminated | |
| Z-2105-2019 | YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control | Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain