FDA applicant

Globalcare

Xiaolan Town, Zhongshan City, CN1 decision2018–20180 recalls

FDA records 1 decision for Globalcare (Xiaolan Town, Zhongshan City, CN) in 2018: 1 510(k) clearance. All are in product code HGX (Pump, Breast, Powered). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Globalcare’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Globalcare by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Globalcare’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Globalcare”

FDA records each applicant name separately; these may or may not be the same firm.

Globalcare Medical Technology Co., Ltd. 5 Globalcare Intl., Inc. 4 Globalcare/Bay Medical Corp. 1

Globalcare

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Globalcare”