KDZClass I

Device, Decalcifier, Electrolytic

Pathology · 21 CFR 864.3010

MDR events3All time

Recalls0All time

Registered firms3Currently listed

510(k) clearances0All time

Recent MDR events

3 adverse event reports on file

MEDEX CLEAR CUFF PRESSURE INFUSORSep 23, 2025
MalfunctionSmiths Medical Asd, Inc.1526863-2025-00112
MEDEX STOPCOCKS INFUSION EXTENSION SETS AND DISPOSApr 24, 2023
InjurySmiths Medical Asd, Inc.3012307300-2023-04453
PLUM XLM SINGLE CHANAug 22, 2003
MalfunctionAbbott Laboratories2921482-2003-00442

Event type breakdown

Malfunction2

Injury1

Most-reported manufacturers

Smiths Medical Asd, Inc.2 Abbott Laboratories1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

3 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.