FDA applicant

Teleflex Medical Sdn. Bhd.

Kamunting, MY3 decisions2026–20260 recalls

FDA records 3 decisions for Teleflex Medical Sdn. Bhd. (Kamunting, MY) in 2026: 3 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

How often FDA has decided Teleflex Medical Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2026

2026high 3 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Teleflex Medical Sdn. Bhd. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Teleflex Medical Sdn. Bhd.’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 “Teleflex”

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

Teleflex Medical 46 Teleflex, Inc. 11 Teleflex Medical Group 1

Teleflex Medical Sdn. Bhd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Teleflex”