510(k) Report

FDA applicant

Shiva Medicare, Ltd.

Baltimore, MD5 decisions1998–19990 recalls

FDA records 5 decisions for Shiva Medicare, Ltd. (Baltimore, MD) from 1998 to 1999: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Shiva Medicare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shiva Medicare, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shiva Medicare, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shiva Medicare, Ltd.’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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Other applicant names beginning “Shiva”

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