FDA applicant

Ergo Intl., Ent., Inc.

North Miami Beach, FL5 decisions1988–19890 recalls

FDA records 5 decisions for Ergo Intl., Ent., Inc. (North Miami Beach, FL) from 1988 to 1989: 5 510(k) clearances. Most are in product codes LYY (Latex 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 Ergo Intl., Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ergo Intl., Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ergo Intl., Ent., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ergo Intl., Ent., Inc.’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 “Ergo”

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

Ergo-Air, Inc. 3 Ergo Instruments, Inc. 1 Ergo-Flex Technologies, LLC 1

Ergo Intl., Ent., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ergo”