Burke Neutech, Inc. FDA Record
Burke Neutech, Inc. has 0 FDA recalls, 0 inspections, 7 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Burke Neutech, Inc." is on file.
- Latest 510(k)
- Apr 10, 1996
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 7 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | Apr 10, 1996 |
| K952117 | EPILATOR | Oct 19, 1995 |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | Jun 7, 1995 |
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | May 11, 1995 |
| K942926 | NEURO-AIDE | Aug 3, 1994 |
| K940160 | TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM | May 27, 1994 |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | May 26, 1993 |
Burke Neutech, Inc. and the FDA: common questions
Has Burke Neutech, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Burke Neutech, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Burke Neutech, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Burke Neutech, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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