Digicare Biomedical Technology, Inc.

FDA Regulatory Profile

Digicare Biomedical Technology, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Feb 6, 2024 · NAI
Latest 510(k)
Sep 25, 2019

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 6, 2024Boynton Beach, FLDevicesNo Action Indicated (NAI)3000718682
Mar 12, 2013Boynton Beach, FLDevicesVoluntary Action Indicated (VAI)3000718682
Aug 3, 2012Boynton Beach, FLDevicesNo Action Indicated (NAI)3000718682

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
K183687LifeWindow LW8 LiteSep 25, 2019