FDA applicant

Shiva Products

Palghar, IN1 decision2024–20240 recalls

FDA records 1 decision for Shiva Products (Palghar, IN) in 2024: 1 510(k) clearance. All are in product code KIF (Resin, Root Canal Filling). 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, dental panel, where it files most

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

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Shiva Products by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shiva Products’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 “Shiva”

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

Shiva Medicare, Ltd. 5

Shiva Products

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Shiva”