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Koala®
CLINICAL INNOVATIONS, LLC · Model IPC-5000E · UDI-DI 00814247020178
HFN
Prescription
9
510(k) clearances
25
Adverse events (6 deaths)
1
Recalls
15
Facilities
Description
Koala® Intrauterine Pressure Catheter with external balloon
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-06-16 | Utah Medical Products, Inc | Possibility of compromised package sterility prior to the expiration date. |
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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.