FDA applicant

Apex Ent., Inc.

Fairfield, NJ1 decision1994–19940 recalls

FDA records 1 decision for Apex Ent., Inc. (Fairfield, NJ) in 1994: 1 510(k) clearance. All are in product code MDM (Instrument, Manual, Surgical, General Use). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Apex Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Apex 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 “Apex”

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

Apex Medical Corp. 36 Apex BioTechnology Corp. 35 Apex Dental Materials, Inc. 15 Apex Medical Technologies, Inc. 8 Apex Surgical, LLC 6 Apex Metal, Inc. 3 Apex Tools & Orthopedics Co. 2 Apex Optical Ind. Co. 1 Apex Medical Products, LLC 1 Apex Technologies, Inc. 1 Apex Orthodontics, Inc. 1 Apex Imaging Corp. 1

Apex Ent., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Apex”