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Custom Medical Specialties, Inc.

CUSTOM ASSEMBLIES, INC. · Model CMS-6056 · UDI-DI 00815849021891

FCP
2
510(k) clearances
2
Adverse events
1
Recalls
2
Facilities

Description

Pocket - Sterile

Recalls

DateFirmReason
2015-02-11EXP Pharmaceutical Services CorpEXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.