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"PREVA, 76"" REACH, DEUTSCH "

Model PE7017-D · MIDMARK CORPORATION · DI 00841709103452

EHD — Unit, X-Ray, Extraoral With Timer · Class II · 21 CFR 872.1800

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222019-01: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device01060212021208100204
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0602
2020-0202
2021-1201.33
2022-0201
2022-1202
2023-0802
2023-1001
2026-0201
2026-0401
This device (reports/month)Average device in EHD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K043092 — cited as predicate by K111330, K120318, K141293

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MIDMARK CORPORATION

  • Warning Letter 2011-12-28 Midmark Corporation
  • Warning Letter 2011-12-28 Midmark Corporation
  • NAI 2024-03-14 Midmark Corporation · 0 citations
  • VAI 2018-04-02 Midmark Corporation · 1 citations
  • VAI 2018-04-02 Midmark Corporation · 1 citations
  • NAI 2017-08-22 Midmark Corporation · 0 citations
  • NAI 2016-12-09 Midmark Corporation · 0 citations
  • NAI 2016-12-09 Midmark Corporation · 0 citations
  • VAI 2014-06-09 Midmark Corporation · 8 citations
  • VAI 2014-06-09 Midmark Corporation · 8 citations
  • VAI 2012-06-28 Midmark Corporation · 4 citations
  • VAI 2012-06-28 Midmark Corporation · 4 citations
  • VAI 2012-03-13 Midmark Corporation · 2 citations
  • OAI 2011-09-12 Midmark Corporation · 8 citations
  • OAI 2011-09-12 Midmark Corporation · 8 citations
  • VAI 2010-02-24 Midmark Corporation · 2 citations