inforMED
NLHClass II

Catheter, Recording, Electrode, Reprocessed

Cardiovascular · 21 CFR 870.1220

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

MDR events449All time
Recalls48All time
Registered firms153Currently listed
510(k) clearances70All time

Recent MDR events

449 adverse event reports on file

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Event type breakdown

Malfunction381
Injury66
Unspecified1
Death1

Most-reported manufacturers

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Stryker Sustainability Solutions Phoenix195Stryker-endoscopy Phoenix Usa108Sterilmed, Inc.63Stryker Sustainability Solutions18Innovative Health, Llc.12Stryker Sustainability Solutions, Inc.9Unspecified5Ascent5

Recalls

48 recall events for this product code

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Registered firms

153 firms currently registered for this product code

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510(k) clearances

70 clearances for this product code

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