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Silk Road Medical, Inc.

1292 adverse events · 7 inspections · 6 clearances · 1 recalls

Scorecard
Events per device across the 40-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

4.50

180 in the last 12 months

Higher volume than 99% of companies with 10+ devices

Recalls per device

0

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
40 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
ENROUTE Transcarotid Neuroprotection SystemSR-200-NPSNTE008113110207441438
ENROUTE Transcarotid Neuroprotection SystemFG12522NTE008113110208291417
"ENROUTE .014"" Guidewire"11686-01DQX00811311020546229
ENROUTE Transcarotid StentSR-0940-CSNIM00811311020508176
ENROUTE Transcarotid StentSR-0840-CSNIM00811311020478164
ENROUTE Transcarotid StentSR-1040-CSNIM00811311020539162
ENROUTE Transcarotid StentSR-0830-CSNIM0081131102046165
ENROUTE Transcarotid StentSR-0930-CSNIM0081131102049264
ENROUTE Transcarotid StentFG11815NIM0081131102129164
ENROUTE Transcarotid StentFG11815NIM0081131102127755
ENROUTE Transcarotid StentFG11815NIM0081131102131452
ENROUTE Transcarotid StentFG11815NIM0081131102126049
ENROUTE Transcarotid StentFG11815NIM0081131102128447
ENROUTE Transcarotid StentFG11815NIM0081131102130742
ENROUTE Transcarotid StentSR-0740-CSNIM0081131102044742
ENROUTE Transcarotid StentFG11815NIM0081131102132142
ENROUTE Transcarotid StentSR-1030-CSNIM0081131102052240
ENROUTE Transcarotid StentSR-0730-CSNIM0081131102043021
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-5535-BCLIT008113110210246
ENROUTE Transcarotid StentSR-0640-CSNIM008113110204166
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-6025-BCLIT008113110209665
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-5035-BCLIT008113110210175
"ENROUTE .014"" Guidewire"11686-01DQX108113110205433
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-5025-BCLIT008113110209423
ENROUTE Transcarotid StentSR-0720-CSNIM008113110204232
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-6035-BCLIT008113110210310
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-5525-BCLIT008113110209590
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-4525-BCLIT008113110209350
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-4535-BCLIT008113110210000
ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSR-4035-BCLIT008113110209970
Showing 1–30 of 40Next →
Facilities
Registered establishments with their latest FDA inspection outcome.

No registered facilities linked.