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

GEX 2018-07-23

GME LinScan Lite 808 Laser System

Applicant Gme German Medical Engineering GmbH

K-Number K180518

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JCX 2018-07-23

DV-300 Aspirator

Applicant Ding Hwa Co., Ltd.

K-Number K181398

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LLZ 2018-07-23

Quantitative Total Extensible Imaging (QTxI)

Applicant Aiq Solutions, Inc.

K-Number K173444

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NKB 2018-07-23

JASPER Spinal Fixation System

Applicant Gbs Commonwealth Co., Ltd.

K-Number K173645

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MBI 2018-07-23

Stryker All-PEEK Knotless Anchor System

Applicant Stryker

K-Number K181083

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FLL 2018-07-23

Braun BNT400 No Touch + Forehead Thermometer

Applicant Kaz USA, Inc., A Helen of Troy Company

K-Number K181242

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FLL 2018-07-23

Non-contact infrared body thermometer

Applicant Hetaida Technology Co., Ltd.

K-Number K171888

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HAW 2018-07-23

Voyager Trajectory Array Guide (V-TAG)

Applicant Voyager Therapeutics, Inc.

K-Number K180854

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MUH 2018-07-20

Aurora

Applicant Sodium Systems, LLC

K-Number K181636

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IZL 2018-07-20

Digital Diagnostic Mobile X-ray System

Applicant Samsung Electronics Co., Ltd.

K-Number K181626

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GXR 2018-07-20

GuardianTM Burr Hole Cover System

Applicant St Jude Medical

K-Number K181382

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LZO 2018-07-20

EcoFit Vit E Acetabular System

Applicant Implantcast GmbH

K-Number K180263

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