Suntech Medical, Inc.
FDA Regulatory Profile
Suntech Medical, Inc. appears in FDA public data with 3 recalls, 8 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2429-2020, Class II) was initiated on Apr 20, 2020. Its most recent 510(k) clearance was granted on Jul 6, 2016.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 8
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2429-2020 | Class II | Oscar 2, Model 250 System | Apr 20, 2020 |
| Z-0810-2020 | Class II | Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part n | Dec 11, 2019 |
| Z-2277-2019 | Class II | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20 | Jun 3, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160439 | SunTech CT40 Spot-check Vital Signs Device | Jul 6, 2016 |
| K151520 | Oscar 2 | Feb 19, 2016 |
| K122401 | TANGO M2 BLOOD PRESSURE MONITOR | Nov 2, 2012 |
| K080854 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 | Oct 20, 2008 |
| K070750 | 247 BP DEVICE | May 2, 2007 |
| K060820 | CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 | Jun 7, 2006 |
| K053209 | TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM | Jan 5, 2006 |
| K051904 | ALL PURPOSE CUFF, MODEL 222APC | Sep 9, 2005 |