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

CFN 2019-08-19

Optilite IgA Kit

Applicant The Binding Site Group , Ltd.

K-Number K191985

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MAX 2019-08-19

Zavation eZspand Interbody System

Applicant Zavation Medical Products, LLC

K-Number K191339

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HWC 2019-08-19

CrossRoads Screw System

Applicant Crossroads Extemity Systems, LLC

K-Number K191342

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JDR 2019-08-16

APTUS Foot System

Applicant Medartis AG

K-Number K191636

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LXV 2019-08-16

EQ Balance

Applicant Upright Science, Inc.

K-Number K190735

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GEX 2019-08-16

980nm Diode Laser Therapy Device

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K191349

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MQB 2019-08-16

SKR 4000

Applicant Konica Minolta, Inc.

K-Number K191645

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JFP 2019-08-16

Stat Profile Prime ES Comp Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K191626

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NUH 2019-08-16

GIM-STIM OTC TENS/EMS System

Applicant Gemore Technology Co, Ltd.

K-Number K190988

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BZC 2019-08-16

Vyntus BODY

Applicant Vyaire Medical, Inc.

K-Number K190853

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HQC 2019-08-16

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

Applicant Johnson & Johnson Surgical Vision, Inc.

K-Number K191933

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NFW 2019-08-16

SAFECARE® THC Urine Strip Test

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K191924

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