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AESCULAP
Model MA594R · AESCULAP, INC. · DI 04046964588648
JZF — Tube, Ear Suction · Class I · 21 CFR 874.4420
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 1 |
| 2025-10 | 0 | 1.5 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — AESCULAP, INC.
- 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