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APN Health LLC

FDA Regulatory Profile

APN Health LLC has 1 FDA recall, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "APN Health LLC" and its spelling variant "Apn Health".

Latest recall
Z-0556-2024 · Class III · Nov 7, 2023
Latest inspection
Sep 1, 2023 · NAI
Latest 510(k)
Feb 23, 2016

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

APN Health LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

APN Health LLC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310010
202200000
202100000
202000000
201910000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

1 recall record on Nov 7, 2023.

NumberClassProductDate
Z-0556-2024Class IIINavik 3D v2, REF NAVIK3D, 3D Mapping SystemNov 7, 2023

Recent FDA inspections

2 inspections from Oct 10, 2019 to Sep 1, 2023.

DateSiteProductClassificationFEI
Sep 1, 2023Brookfield, WIDevicesNo Action Indicated (NAI)3014282601
Oct 10, 2019Brookfield, WIDevicesVoluntary Action Indicated (VAI)3014282601
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014282601Brookfield, WI2Sep 1, 2023

Recent 510(k) clearances

1 510(k) clearance on Feb 23, 2016.

K-NumberDeviceDate
K152160Navik 3DFeb 23, 2016

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.