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Roxwood Medical, Inc.

FDA Regulatory Profile

Roxwood Medical, Inc. has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 29, 2016 · NAI
Latest 510(k)
Mar 7, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances8Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 29, 2016Redwood City, CADevicesNo Action Indicated (NAI)3010034168

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K170403CenterCross Ultra LV CatheterMar 7, 2017
K160681CenterCross Ultra CatheterJun 17, 2016
K152957MultiCross CatheterMar 4, 2016
K152456CenterCross Ultra CatheterJan 26, 2016
K151082MicroCross CatheterJun 7, 2015
K143744MicroCross CatheterApr 14, 2015
K140910CENTERCROSS CATHETERNov 19, 2014
K121763MULTICROSS SUPPORT CATHETERNov 27, 2012

FDA data resources