FDA applicant

Performance Medical, Inc.

Great Neck, NY1 decision1990–19900 recalls

FDA records 1 decision for Performance Medical, Inc. (Great Neck, NY) in 1990: 1 510(k) clearance. All are in product code LKY (Device, External Penile Rigidity). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Performance Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Performance Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Performance”

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

Performance Surgical Instruments Corp. 2 Performance Instruments Corp. 1 Performance Plus, Inc. 1 Performance, Inc. 1 Performance Hyperbarics 1 Performance Water Systems, LLC 1 Performance Ent. 1

Performance Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Performance”