IODOFLEX— 510(k) K190756
Substantially EquivalentSmith & Nephew Medical, Ltd.
FDA 510(k) clearance K190756 for IODOFLEX, Substantially Equivalent on 2019-12-20. Applicant: Smith & Nephew Medical, Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Smith & Nephew Medical, Ltd.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hull East Riding Of Yorkshire, GB
Recent devices under product code FRO
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- K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.