Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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OCL 2021-07-26

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

Applicant AtriCure, Inc.

K-Number K210477

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FXX 2021-07-25

MASC Surgical Mask

Applicant Mid-America Safety Corp.

K-Number K211984

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FXX 2021-07-24

Medical Face Mask

Applicant Hubei Kangning Protective Products Co., Ltd.

K-Number K211363

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LYZ 2021-07-24

Disposable Vinyl Nitrile Synthetic Gloves Powder Free

Applicant Tangshan Hongyun Healthcare Products Co., Ltd.

K-Number K211262

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