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ACS
AMERICAN CONTRACT SYSTEMS, INC. · Model SJBE44E · UDI-DI 00191072076151
0
510(k) clearances
18
Adverse events
1
Recalls
11
Facilities
Description
BASIC EAR SJH
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-02-10 | Thermedx LLC | A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual |
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Get your free API keyRead the docsData 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.