Ximedica

FDA Regulatory Profile

Ximedica appears in FDA public data with 0 recalls, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Apr 13, 2022 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Apr 1, 2024.

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Summary

Total Recalls
0
510(k) Clearances
2
Inspections
4
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 13, 2022Providence, RIDevicesVoluntary Action Indicated (VAI)3006463947
Aug 14, 2019Providence, RIDevicesNo Action Indicated (NAI)3006463947
May 16, 2017Providence, RIDevicesNo Action Indicated (NAI)3006463947
May 11, 2010Providence, RIDevicesNo Action Indicated (NAI)3006463947

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K240635ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT SpeciApr 1, 2024
K232519ENDOCOLLECT Specimen Retrieval BagJan 5, 2024