inforMED
KZLClass II

Device, Warming. Blood And Plasma

Hematology · 21 CFR 864.9205

MDR events828All time
Recalls0All time
Registered firms18Currently listed
510(k) clearances4All time

Recent MDR events

828 adverse event reports on file

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Event type breakdown

Malfunction805
Injury14
Death8
Unspecified1

Most-reported manufacturers

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Smiths Medical Asd, Inc.268St Paul245Smiths Healthcare Manufacturing S.a. De C.v.88Stryker Medical-kalamazoo75Icu Medical Manufacturing S.a. De C.v.20Icu Medical Healthcare Manufacturing S.a. De C.v.19Smiths Medical Asd, Inc.,19Smiths Medical Asd; Inc.13

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

18 firms currently registered for this product code

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510(k) clearances

4 clearances for this product code

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