openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
These labels are deterministic app interpretations, not FDA categories.
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
