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20GA Forceps - Sterile

Model PD420.00S · Peregrine Surgical, Llc · DI 00632307000089

HNR — Forceps, Ophthalmic · Class I · 21 CFR 886.4350

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.

12342019-03: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.33/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 1.33/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 2.17/device2022-09: 0 reports for this device; peer average 1.33/device2022-10: 0 reports for this device; peer average 2.33/device2022-11: 0 reports for this device; peer average 3.5/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 1.33/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2.64/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1.4/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.33/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1.38/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.75/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1.4/device2025-01: 0 reports for this device; peer average 1.25/device2025-02: 0 reports for this device; peer average 1.4/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.8/device2025-05: 0 reports for this device; peer average 1.83/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.29/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2.4/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1.43/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1.25/device03050709110103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301.5
2019-0501
2019-0701.5
2019-0901
2019-1103
2020-0101
2021-0302
2021-0402
2021-0501
2021-0601
2021-0702
2021-0802
2021-0901.33
2021-1001.67
2021-1101.33
2021-1202
2022-0101
2022-0201
2022-0301
2022-0401
2022-0501.5
2022-0601.67
2022-0701
2022-0802.17
2022-0901.33
2022-1002.33
2022-1103.5
2022-1201
2023-0101.75
2023-0201.33
2023-0301
2023-0402
2023-0501
2023-0602.64
2023-0701
2023-0801.4
2023-0902
2023-1001.33
2023-1101
2023-1201.25
2024-0101.5
2024-0201
2024-0301
2024-0401.38
2024-0501
2024-0601.75
2024-0701.67
2024-0801.5
2024-0901
2024-1001
2024-1102
2024-1201.4
2025-0101.25
2025-0201.4
2025-0301.75
2025-0401.8
2025-0501.83
2025-0601
2025-0701.33
2025-0801
2025-0901
2025-1001
2025-1101.29
2025-1202
2026-0102.4
2026-0201.5
2026-0301
2026-0401.43
2026-0501
2026-0601.25
This device (reports/month)Average device in HNR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Peregrine Surgical, Llc

  • Warning Letter 2010-12-20 Peregrine Surgical Ltd
  • Warning Letter 2010-12-20 Peregrine Surgical Ltd
  • NAI 2018-09-26 Peregrine Surgical Ltd · 0 citations
  • NAI 2018-09-26 Peregrine Surgical Ltd · 0 citations
  • VAI 2015-06-19 Peregrine Surgical Ltd · 0 citations
  • VAI 2015-06-19 Peregrine Surgical Ltd · 0 citations
  • VAI 2013-02-07 Peregrine Surgical Ltd · 1 citations
  • VAI 2013-02-07 Peregrine Surgical Ltd · 1 citations
  • VAI 2011-06-30 Peregrine Surgical Ltd · 0 citations
  • VAI 2011-06-30 Peregrine Surgical Ltd · 0 citations
  • OAI 2010-07-15 Peregrine Surgical Ltd · 6 citations
  • OAI 2010-07-15 Peregrine Surgical Ltd · 6 citations