FDA Device Intelligence
HomeENGINEERED MEDICAL SYSTEMS INC › Pulmonary Function Filter

Pulmonary Function Filter

ENGINEERED MEDICAL SYSTEMS INC · Model 301-436 · UDI-DI 00841470100230

BZG Prescription
1
510(k) clearances
31
Adverse events
1
Recalls
93
Facilities

Recalls

DateFirmReason
2024-10-11Baxter Healthcare CorporationThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System

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
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.