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George King AMR von Willebrand Kit

Model 0014-10 · GEORGE KING BIO-MEDICAL, INC · DI 00815696020474

GGC — Control, Plasma, Abnormal · Class II · 21 CFR 864.5425

GGN — Plasma, Coagulation Control · Class II · 21 CFR 864.5425

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.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2021-03	0	1

This device (reports/month)Average device in GGC, GGN (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Manufacturer compliance record — GEORGE KING BIO-MEDICAL, INC

NAI 2025-07-16 George King Bio-Medical, Inc. · 0 citations
NAI 2025-07-16 George King Bio-Medical, Inc. · 0 citations
NAI 2022-10-13 George King Bio-Medical, Inc. · 0 citations
NAI 2022-10-13 George King Bio-Medical, Inc. · 0 citations
VAI 2017-09-06 George King Bio-Medical, Inc. · 6 citations
VAI 2017-09-06 George King Bio-Medical, Inc. · 6 citations
VAI 2016-10-27 George King Bio-Medical, Inc. · 0 citations
VAI 2016-10-27 George King Bio-Medical, Inc. · 0 citations
NAI 2014-11-13 George King Bio-Medical, Inc. · 0 citations
NAI 2014-11-13 George King Bio-Medical, Inc. · 0 citations
NAI 2012-10-16 George King Bio-Medical, Inc. · 0 citations
NAI 2012-10-16 George King Bio-Medical, Inc. · 0 citations