inforMED
QRKClass II

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

General, Plastic Surgery · 21 CFR 878.4850

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

MDR events45All time
Recalls0All time
Registered firms106Currently listed
510(k) clearances16All time

Recent MDR events

45 adverse event reports on file

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Event type breakdown

Malfunction40
Injury5

Most-reported manufacturers

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Trividia Health Inc31Roche Diabetes Care, Inc.8Livongo Health Inc2Teladoc Health, Inc.2Livongo Health1Teladoc Health Inc.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

106 firms currently registered for this product code

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510(k) clearances

16 clearances for this product code

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