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

PBX 2019-02-22

Doctor Tecar

Applicant Mectronic Medicale S.R.L.

K-Number K183693

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JCX 2019-02-21

ZOOM Aspiration Pump

Applicant Taiwan Biomaterial Co., Ltd.

K-Number K190105

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JAD 2019-02-21

Sensus Healthcare TVM Balloon Applicator

Applicant Sensus Healthcare, Inc.

K-Number K190255

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MUJ 2019-02-21

Sensus TPS Workstation

Applicant Sensus Healthcare, Inc.

K-Number K182665

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DZE 2019-02-21

NobelParallel Conical Connection

Applicant Nobel Biocare AB

K-Number K173418

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JOW 2019-02-21

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

Applicant Devon Medical Products (Jiangsu), Ltd.

K-Number K182578

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GJS 2019-02-21

Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

Applicant Coagusense, Inc.

K-Number K183255

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JAD 2019-02-21

Sensus IORT System

Applicant Sensus Healthcare, Inc.

K-Number K182641

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MBI 2019-02-21

HEALIX Ti ANCHOR with DYNACORD

Applicant Medos International SARL

K-Number K183279

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LON 2019-02-20

VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

Applicant bioMerieux, Inc.

K-Number K183415

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EKX 2019-02-20

AnyCheck IMT-100

Applicant Dms Co., Ltd.

K-Number K180953

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IYE 2019-02-20

MRIdian Linac System

Applicant Viewray, Incorporated

K-Number K181989

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