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Rectoscope equipment
SAPI MED SPA · Model Rectoscope equipment with LED and insufflator · UDI-DI 08033638801536
KDM
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities
Description
Non-sterile and disposable rectoscope equipment of 12,5mm diameter with insufflator and built-in LED light.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-23 | Adler MicroMed, Inc. | Due to issue with product sterility. Sterilization service provider had falsified records. |
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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.