FDA applicant

Mectra Labs, Inc.

Bloomfield, IN9 decisions1992–20120 recalls

FDA records 9 decisions for Mectra Labs, Inc. (Bloomfield, IN) from 1992 to 2012: 9 510(k) clearances. Most are in product codes HIF (Insufflator, Laparoscopic) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mectra Labs, 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 “Mectra”

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

Mectra Laboratories, Inc. 1

Mectra Labs, 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 “Mectra”