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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

  • European UnionMako08858251002237SK
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2018-02-23VAIVoluntary action indicatedMako Surgical Corporation2
2014-11-25NAINo action indicatedMako Surgical Corporation0
2014-08-11VAIVoluntary action indicatedMako Surgical Corporation3
2013-02-26VAIVoluntary action indicatedMako Surgical Corporation2
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