FDA applicant

Titan Manufacturing, Inc.

Malvern, PA1 decision2021–202145 recalls

FDA records 1 decision for Titan Manufacturing, Inc. (Malvern, PA) in 2021: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 3 predicates, 0 of them its own earlier devices. 45 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

45in 2022

2021high 45 (2022) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Titan Manufacturing, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Titan Manufacturing, Inc.’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 “Titan”

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

Titan Spine, LLC 19 Titan Tables 4 Titan Implants 4 Titan Medical, Inc. 3 Titan Mfg., Inc. 3 Titan Condoms, LLC 2 Titan Technology Intl., Inc. 1

Titan Manufacturing, Inc.

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 “Titan”