FDA applicant
Tomarc (M) Sdn Bhd
FDA records 5 decisions for Tomarc (M) Sdn Bhd (Kuala Lumpar, MY) from 1989 to 1993: 5 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and JTN (Susceptibility Test Discs, Antimicrobial). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tomarc (M) Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Tomarc (M) Sdn Bhd since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tomarc (M) Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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