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B&J Manufacturing , Ltd.

FDA Regulatory Profile

B&J Manufacturing , Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 27, 2015 · NAI
Latest 510(k)
Sep 19, 2020

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 27, 2015Shenzhen, ChinaDevicesNo Action Indicated (NAI)3010190204

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
K201532B&J DVT Calf/Thigh Garments, Models 801/830 SeriesSep 19, 2020
K201547B&J DVT Foot Garments, Models 820 SeriesSep 18, 2020
K200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemJul 10, 2020
K200154B&J DVT Compression Devices MHH800/MHH800SQJul 8, 2020

FDA data resources