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Ambler Surgical

Model Utility plaster shears · AMBLER SURGICAL CORP. · DI 00190660171995

HRR — Scissors, Orthopedic, Surgical · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-15 · 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.

12342020-06: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device06030407
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0604
2023-0303
2023-0403
2023-0703
This device (reports/month)Average device in HRR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMBLER SURGICAL CORP.

Nothing in the loaded window.