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BIOPHEN LMWH Control Low

Model 223701 · HYPHEN BIOMED · DI 03663537008368

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

UDILibrary device dossier · generated 2026-09-14 · 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.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — HYPHEN BIOMED

  • Warning Letter 2012-09-05 Hyphen BioMed sasu
  • OAI 2014-02-13 Hyphen BioMed sasu · 0 citations
  • OAI 2012-06-20 Hyphen BioMed sasu · 5 citations