510(k) Report

FDA applicant

Manan Medical Products, Inc.

Northbrook, IL39 decisions1988–20058 recalls

FDA records 39 decisions for Manan Medical Products, Inc. (Northbrook, IL) from 1988 to 2005: 39 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Its devices cite 3 predicates, 2 of them its own earlier devices. 8 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 Manan Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Manan Medical Products, Inc. since 2007.

Recalls per year

7in 2018

2018: 7
2007high 7 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Manan Medical Products, 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 “Manan”

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