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

IYE 2020-11-12

ExacTrac Dynamic

Applicant Brainlab AG

K-Number K203173

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GWN 2020-11-12

Insight Infrared Video Goggles

Applicant Vestibular First

K-Number K203082

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FRG 2020-11-12

Tyvek Sterilization Pouches with Chevron Seal

Applicant Andersen Sterilizers, Inc.

K-Number K200336

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FRG 2020-11-12

Sterisheet Sterilization Wrap

Applicant Andersen Sterilizers, Inc.

K-Number K200335

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HSD 2020-11-12

AGILON® XO Shoulder Replacement System

Applicant Implantcast GmbH

K-Number K191433

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QJP 2020-11-11

Route 92 Medical 070 Access System

Applicant Route 92 Medical, Inc.

K-Number K203043

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DZE 2020-11-10

JTK Dental Implant System

Applicant Jiangyin Jintech Biotech Co., Ltd.

K-Number K183044

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ETN 2020-11-10

StimSite

Applicant Allotrope Medical, Inc.

K-Number K200886

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NUC 2020-11-10

VagiVital Aktivgel

Applicant Peptonic Medical AB

K-Number K200098

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MBI 2020-11-10

WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws

Applicant Biomet, Inc.

K-Number K193214

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MBI 2020-11-10

Multi-Drive Interference Screw System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K200428

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MUD 2020-11-10

SnapshotNIR

Applicant Kent Imaging

K-Number K201976

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