OEWClass IILife-sustaining

Tracking, Soft Tissue, Intraoperative

Neurology · 21 CFR 882.4560

For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

MDR events1All time

Recalls1All time

Registered firms8Currently listed

510(k) clearances4All time

Recent MDR events

1 adverse event reports on file

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UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEMAug 17, 2012
MalfunctionBeckman Coulter, Inc.2122870-2012-01682

Event type breakdown

Malfunction1

Most-reported manufacturers

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Beckman Coulter, Inc.1

Recalls

1 recall events for this product code

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MEDLINE INDUSTRIES, LP - Northfield
Open, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2994-2024 · View FDA record ↗

Registered firms

8 firms currently registered for this product code

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510(k) clearances

4 clearances for this product code

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