510(k) Report

FDA product code · Ear, nose and throat

Prosthesis, Facial, Mandibular Implant

JAZClass II21 CFR 874.3695510(k) required2 decisions since 19820 recalls

2 FDA decisions since 1982. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ear, nose and throat panel

Twenty years of JAZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · JAZ

FDA has decided no JAZ device since 2007.

Median 510(k) review, days · JAZ

Too few JAZ 510(k)s in any year since 2007 to give a median.

Recalls per year · JAZ

No recall names JAZ since 2007.

Adverse event reports per year · JAZ

1in 2024

2007: 82008: 42009: 72010: 22024: 1
2007high 8 (2007) · low 0 (2011)2025

MAUDE reports naming product code JAZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—08
20080—04
20090—07
20100—02
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — JAZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JAZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report