Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Suntech Medical with 8 510(k) clearances and 3 device recalls. The most recent is a device recall dated Apr 20, 2020: Oscar 2, Model 250 System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 20, 2020 | Oscar 2, Model 250 SystemClass II · The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit | Device recalls |
| Dec 11, 2019 | Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part numbClass II · The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user saf | Device recalls |
| Jun 3, 2019 | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20Class II · Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the | Device recalls |
| Jul 6, 2016 | SunTech CT40 Spot-check Vital Signs DeviceK160439 · DXN | 510(k) clearances |
| Feb 19, 2016 | Oscar 2K151520 · DXN | 510(k) clearances |
| Nov 2, 2012 | TANGO M2 BLOOD PRESSURE MONITORK122401 · DXN | 510(k) clearances |
| Oct 20, 2008 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100K080854 · DXQ | 510(k) clearances |
| May 2, 2007 | 247 BP DEVICEK070750 · DXN | 510(k) clearances |
| Jun 7, 2006 | CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060K060820 · DXN | 510(k) clearances |
| Jan 5, 2006 | TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEMK053209 · DXN | 510(k) clearances |
| Sep 9, 2005 | ALL PURPOSE CUFF, MODEL 222APCK051904 · DXQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
