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

OWB 2019-08-20

ARCO FP

Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L.

K-Number K182086

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LPH 2019-08-20

iNSitu Total Hip System

Applicant Thecken Companies, LLC

K-Number K191936

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DXN 2019-08-19

Blood Pressure Monitor

Applicant Shenzhen Viatom Technology Co., Ltd.

K-Number K190207

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FRG 2019-08-19

Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Applicant Weihai Xingtai Packaging Products Co., Ltd.

K-Number K183356

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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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