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Amplifi

Model AMPLIFI-15X20 · COLLAGEN MATRIX, INC. · DI 00813954025285

NPL — Barrier, Animal Source, Intraoral · Class II · 21 CFR 872.3930

UDILibrary device dossier · generated 2026-09-11 · 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.

369122019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.33/device2020-05: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 9/device2022-04: 0 reports for this device; peer average 5.5/device2022-10: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 12/device2024-10: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2.5/device2025-12: 0 reports for this device; peer average 3.14/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 1/device0910120503010410020304081004050612020305
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0902
2019-1001
2019-1201.33
2020-0501
2021-0301
2022-0109
2022-0405.5
2022-1002
2023-0202
2024-0302
2024-0402
2024-08012
2024-1003
2025-0401.5
2025-0501
2025-0602.5
2025-1203.14
2026-0202
2026-0303
2026-0501
This device (reports/month)Average device in NPL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — COLLAGEN MATRIX, INC.

  • Warning Letter 2016-09-20 Collagen Matrix, Inc.
  • Warning Letter 2016-09-20 Collagen Matrix, Inc.
  • Warning Letter 2015-01-08 Collagen Matrix, Inc.
  • Warning Letter 2015-01-08 Collagen Matrix, Inc.
  • VAI 2017-07-18 Collagen Matrix Inc · 3 citations
  • VAI 2017-07-18 Collagen Matrix Inc · 3 citations
  • NAI 2017-07-13 Collagen Matrix, Inc. · 0 citations
  • NAI 2017-07-13 Collagen Matrix, Inc. · 0 citations
  • OAI 2015-11-25 Collagen Matrix, Inc. · 2 citations
  • OAI 2015-11-25 Collagen Matrix, Inc. · 2 citations
  • VAI 2011-12-05 Collagen Matrix, Inc. · 3 citations
  • VAI 2011-12-05 Collagen Matrix Inc · 3 citations
  • VAI 2011-12-05 Collagen Matrix, Inc. · 3 citations
  • VAI 2011-12-05 Collagen Matrix Inc · 3 citations