FDA applicant

Apple Medical Corp.

Marlboro, MA9 decisions1994–200610 recalls

FDA records 9 decisions for Apple Medical Corp. (Marlboro, MA) from 1994 to 2006: 9 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 4 predicates, 2 of them its own earlier devices. 10 recalls are 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 Apple Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Apple Medical Corp. since 2007.

Recalls per year

1in 2022

2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Apple Medical Corp.’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 “Apple”

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

Apple, Inc. 12 Apple Diagnostic Products 7

Apple Medical Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Apple”