FDA applicant

P.T. Latexindo Tobaperkasa

Medan, ID3 decisions1997–19980 recalls

FDA records 3 decisions for P.T. Latexindo Tobaperkasa (Medan, ID) from 1997 to 1998: 3 510(k) clearances. Most are in product codes LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball) and LYZ (Vinyl Patient Examination Glove). 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, general hospital panel, where it files most

How often FDA has decided P.T. Latexindo Tobaperkasa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P.T. Latexindo Tobaperkasa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — P.T. Latexindo Tobaperkasa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like P.T. Latexindo Tobaperkasa’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

P.T. Latexindo Tobaperkasa

Which product codes does it file in?

What has FDA decided for it lately?