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"System module ""Instru-Safe"""
Model 80-605-00 · Spiggle & Theis Medizintechnik GmbH · DI 04250381850978
MMO — Tray, Surgical, Ent · Class I · 21 CFR 874.4420
UDILibrary device dossier · generated 2026-09-14 · 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) |
|---|---|---|
| 2019-09 | 0 | 7 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Spiggle & Theis Medizintechnik GmbH
Nothing in the loaded window.