Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NAY 2021-07-27

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K211325

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EIH 2021-07-27

1Derful HS, 1Derful HT

Applicant 1derful, Inc.

K-Number K210884

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QJP 2021-07-27

Route 92 Medical Full Length 088 Access System

Applicant Route 92 Medical, Inc.

K-Number K210635

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QIH 2021-07-27

Us2.v1

Applicant Eko.Ai Pte Ltd. D/B/A Us2.Ai

K-Number K210791

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LLZ 2021-07-27

ClariCT.AI

Applicant Claripi, Inc.

K-Number K212074

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DQD 2021-07-27

doctorgram Stethoscope DES-I

Applicant Gv Concepts

K-Number K210736

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DJG 2021-07-27

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

Applicant Psychemedics Corporation

K-Number K201326

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DYB 2021-07-27

Aveir Introducer

Applicant ABBOTT MEDICAL

K-Number K211989

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LLZ 2021-07-27

Volpara Imaging Software

Applicant Volpara Health Technologies Limited

K-Number K211279

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EBF 2021-07-26

Pac-Dent Ceramic Nanohybrid Resin

Applicant Pac-Dent, Inc.

K-Number K210412

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GWE 2021-07-26

Vision Monitor - MonpackONE

Applicant Metrovision

K-Number K211643

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PZJ 2021-07-26

OncoMate MSI Dx Analysis System

Applicant Promega Corporation

K-Number K200129

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