Suntech Medical, Inc.
Suntech Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2016, with 3 FDA device recalls on record.
Top product codes for Suntech Medical, Inc.
FDA recalls by Suntech Medical, Inc.
- Z-2429-2020 — Oscar 2, Model 250 System
- Z-0810-2020 — Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
- Z-2277-2019 — SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Suntech Medical, Inc.
- K151520 — Oscar 2
- K122401 — TANGO M2 BLOOD PRESSURE MONITOR
- K080854 — DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
- K070750 — 247 BP DEVICE
- K060820 — CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
- K053209 — TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
- K051904 — ALL PURPOSE CUFF, MODEL 222APC
Data sourced from openFDA. This site is unofficial and independent of the FDA.