B-K Medical Aps
B-K Medical Aps has 0 FDA recalls, 0 inspections, 11 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- May 30, 2014
Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 11 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Ge Healthcare | 573 | 169 | 37 | 0 | Jul 31, 2026 (Z-3171-2026) |
| G.E. Healthcare | 0 | 0 | 1 | 0 | — |
| Bk Medical Aps | 0 | 9 | 0 | 0 | — |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K140428 | ULTRASOUND SCANNER SYSTEM BK2300 | May 30, 2014 |
| K132346 | ULTRASOUND SCANNER PRO FOCUS 2202 | Jan 10, 2014 |
| K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 | Jan 10, 2014 |
| K132677 | ULTRASOUND SCANNER FLEX FOCUS 1202 | Jan 7, 2014 |
| K132685 | ULTRASOUND SCANNER PRO FOCUS 2202 | Jan 6, 2014 |
| K123254 | ULTRASOUND SCANNER FLEX FOCUS | Feb 13, 2013 |
| K100919 | PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 | Dec 16, 2011 |
| K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824… | Feb 2, 2009 |
| K081323 | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 | Jul 22, 2008 |
| K081154 | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | May 23, 2008 |
| K070077 | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 | Mar 5, 2007 |