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

JOY 2020-10-02

X100 with Full Field Peripheral Blood Smear (PBS) Application

Applicant Scopio Labs , Ltd.

K-Number K201301

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LNH 2020-10-02

LiverMultiScan

Applicant Perspectum, Ltd.

K-Number K202170

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DRY 2020-10-02

Quantum Workstation 12 Elite

Applicant Spectrum Medical , Ltd.

K-Number K202557

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LLZ 2020-10-02

Cleerly Labs v2.0

Applicant Cleerly, Inc.

K-Number K202280

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NPL 2020-10-02

OssGuide

Applicant Sk Bioland Co., Ltd.

K-Number K200623

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OVD 2020-10-02

Oculus-SA Lumbar Cage System

Applicant Neurostructures

K-Number K202190

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PHL 2020-10-02

HAL for Medical Use(Lower Limb type)

Applicant Cyberdyne, Inc.

K-Number K201559

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KGO 2020-10-02

Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs

Applicant Hartalega Sdn Bhd

K-Number K201748

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LYC 2020-10-02

OsOpia Synthetic Bone Void Filler

Applicant Revisios BV

K-Number K201546

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LQZ 2020-10-02

Slow Wave DS8

Applicant Slow Wave, Inc.

K-Number K191320

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KLE 2020-10-02

BZF-29

Applicant GC America, Inc.

K-Number K200682

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DSB 2020-10-02

SOZO Body Fluid Analyzer

Applicant ImpediMed Limited

K-Number K193410

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