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Medwaves, Inc.

FDA Regulatory Profile

Medwaves, Inc. has 0 FDA recalls, 3 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 18, 2025 · NAI
Latest 510(k)
Nov 25, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 18, 2025San Diego, CADevicesNo Action Indicated (NAI)3005382058
Sep 12, 2023San Diego, CADevicesNo Action Indicated (NAI)3005382058
Sep 5, 2014San Diego, CADevicesNo Action Indicated (NAI)3005382058

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K192406AveCure BT Microwave Ablation SystemNov 25, 2020
K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure…Aug 26, 2015
K083537MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEMJan 15, 2009
K070356MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEMDec 18, 2007

FDA data resources