Caradyne, Ltd.
Mccordsville, IN, US
Caradyne, Ltd. appears in FDA device records in Mccordsville, IN. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Caradyne, Ltd. between 1999 and 2004. The busiest year on record is 2000, with 2. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM | BZD | Substantially Equivalent | |
| K023565 | OXICHECK | CCL | Substantially Equivalent | |
| K000959 | CRITERION 60 OR PM 60 | CAP | Substantially Equivalent | |
| K992101 | CRITERION 40 OR PM 40 | CAP | Substantially Equivalent | |
| K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | BYE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain