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PMT® Suction Instruments

Model 9001-03-100T · PMT CORPORATION · DI 00650551100973

GZX — Instrument, Microsurgical · Class I · 21 CFR 882.4525

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.

11222019-06: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device060801020910110710111201050710
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0602
2019-0802
2021-0101
2022-0201
2022-0902
2022-1002
2022-1101
2023-0702
2023-1002
2023-1101
2024-1202
2025-0101
2025-0501
2025-0701
2025-1001
This device (reports/month)Average device in GZX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — PMT CORPORATION

  • Warning Letter 2009-12-03 PMT Corporation
  • Warning Letter 2009-12-03 PMT Corporation
  • VAI 2024-02-15 PMT Corporation · 4 citations
  • VAI 2024-02-15 PMT Corporation · 4 citations
  • NAI 2017-03-23 PMT Corporation · 2 citations
  • NAI 2017-03-23 PMT Corporation · 2 citations
  • NAI 2013-06-06 PMT Corporation · 7 citations
  • NAI 2013-06-06 PMT Corporation · 7 citations
  • VAI 2010-07-16 PMT Corporation · 0 citations
  • VAI 2010-07-16 PMT Corporation · 0 citations