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ACTIV L

Model FW985R · Aesculap AG · DI 04038653431366

QLQ — Manual Instruments Designed For Use With Total Disc Replacement Devices · Class II · 21 CFR 888.4515

UDILibrary device dossier · generated 2026-09-12 · 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.

12342019-06: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 4/device2019-12: 0 reports for this device; peer average 4/device2020-01: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 4/device0610120103070804110203
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0602
2019-1004
2019-1204
2020-0102
2020-0304
2020-0701
2020-0802
2021-0403
2021-1101
2022-0201
2022-0304
This device (reports/month)Average device in QLQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Aesculap AG

  • Warning Letter 2011-09-26 Aesculap AG
  • Warning Letter 2011-09-26 Aesculap AG
  • NAI 2025-07-11 Aesculap Inc · 0 citations
  • NAI 2025-07-11 Aesculap Inc · 0 citations
  • NAI 2022-07-21 Aesculap AG · 0 citations
  • NAI 2022-07-21 Aesculap AG · 0 citations
  • VAI 2021-08-11 Aesculap Inc · 3 citations
  • VAI 2021-08-11 Aesculap Inc · 3 citations
  • VAI 2018-06-13 Aesculap Inc · 0 citations
  • VAI 2018-06-13 Aesculap Inc · 0 citations
  • NAI 2016-09-22 Aesculap AG · 0 citations
  • NAI 2016-09-22 Aesculap AG · 0 citations
  • VAI 2016-09-14 Aesculap Inc · 0 citations
  • VAI 2016-09-14 Aesculap Inc · 0 citations
  • NAI 2016-07-13 Aesculap Inc · 0 citations
  • NAI 2016-07-13 Aesculap Inc · 0 citations
  • NAI 2015-07-16 Aesculap AG · 1 citations
  • NAI 2015-07-16 Aesculap AG · 1 citations
  • NAI 2015-05-05 Aesculap Inc · 0 citations
  • NAI 2015-05-05 Aesculap Inc · 0 citations
  • NAI 2014-10-23 Aesculap Inc · 0 citations
  • NAI 2014-10-23 Aesculap Inc · 0 citations