MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)— 510(k) K133934

Substantially Equivalent

Links Medical Products, Inc.

FDA 510(k) clearance K133934 for MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER), Substantially Equivalent on 2014-05-02. Applicant: Links Medical Products, Inc..

Clearance details

Applicant: Links Medical Products, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2013-12-23
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, 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, 2020-01-01 through 2026-04-23. 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.