Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP— 510(k) K173276
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K173276 for Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP, Substantially Equivalent on 2018-07-02. Applicant: Medline Industries, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
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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 →
Recalls naming K173276
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173276.
Data sourced from openFDA. This site is unofficial and independent of the FDA.