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

NWM 2021-08-05

ARK Lacosamide Assay

Applicant Ark Diagnostics, Inc.

K-Number K201089

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DQK 2021-08-05

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K210680

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MAX 2021-08-05

Lateral Spine Truss System (LSTS) Interbody Fusion Device

Applicant 4Web Medical, Inc.

K-Number K211388

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LNH 2021-08-04

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K212056

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LFL 2021-08-04

Ultrasonic Bipolar Generator USG-410 with accessories

Applicant Olympus Medical Systems Corporation

K-Number K211838

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DQD 2021-08-04

PrevisEA Device

Applicant Entac Medical, Inc.

K-Number K211068

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IRP 2021-08-04

V12 PRO

Applicant Slk Medical GmbH

K-Number K210913

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NHA 2021-08-04

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K203464

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LZA 2021-08-04

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

Applicant Hengchang (Dongying) Medical Technology Co., Ltd.

K-Number K211714

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PHX 2021-08-04

Tecomet Global Unite Short Stem Instrumentation

Applicant Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

K-Number K211553

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FXX 2021-08-04

Disposable Surgical Face Mask

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K210643

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MBI 2021-08-04

Tigon Medical Button System

Applicant Tigon Medical

K-Number K211049

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