FDA Device Intelligence
HomeMedikro Oy › M915-PCD, PCD Spirometer Kit

M915-PCD, PCD Spirometer Kit

Medikro Oy · Model M9488-PCD · UDI-DI 06420099001094

BZG Prescription
10
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.