FDA Device Intelligence
HomeConcordance Healthcare Solutions LLC › HCS Sourcing

HCS Sourcing

Concordance Healthcare Solutions LLC · Model 99002 · UDI-DI 00810132044281

EFN
10
510(k) clearances
7
Adverse events
2
Recalls
206
Facilities

Description

COTTON BALL LARGE STERILE 100% COTTON

Recalls

DateFirmReason
2022-08-02Carwild CorporationSterility with new cotton source not validated
2016-03-31American Surgical CompanyProduct packaging defective compromising sterility

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.