FDA Device Intelligence
Home › Device types › QJZ

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

FDA product code QJZ · Class 2 · Cardiovascular

4
Registered devices
505
Adverse events
2
Recalls
4
510(k) clearances

Devices with this code

Novalung System — XENIOS AGNovalung System — XENIOS AGVENTANA CLDN18 (43-14A) RxDx Assay — Ventana Medical Systems, Inc.VitalFlow Set — MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Recent recalls

DateFirmReason
2024-04-08Fresenius Medical Care Holdings, Inc.Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) a
2021-12-07Fresenius Medical Care Holdings, Inc.Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.