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Meril Healthcare Pvt. , Ltd.

FDA Regulatory Profile

Meril Healthcare Pvt. , Ltd. has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 6, 2016 · NAI
Latest 510(k)
May 9, 2023

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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) clearances7Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 6, 2016Chala, Vapi, IndiaDevicesNo Action Indicated (NAI)3010846112

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
K222436Latitud™ Hip Replacement SystemMay 9, 2023
K222816Opulent TiNbN Coated KneeNov 18, 2022
K212839Opulent TiNbN Coated KneeNov 16, 2021
K183532Latitud Hip Replacement SystemJul 18, 2019
K172857Latitud Hip Replacement SystemJul 19, 2018
K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and…Mar 8, 2018
K172936Destiknee™ Total Knee SystemNov 30, 2017

FDA data resources