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CARDINAL HEALTH

Cardinal Health 200, LLC · Model SMA11DPL10 · UDI-DI 10197106192573

PAA Prescription
0
510(k) clearances
8
Adverse events
1
Recalls
4
Facilities

Description

SURGICOUNT D C PACK

Recalls

DateFirmReason
2013-05-16U-systems IncDevices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) produ

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

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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.