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

FOZ 2019-09-20

Supercath 5

Applicant Togo Medikit Co., Ltd.

K-Number K190001

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PSY 2019-09-20

Philips IntelliSite Pathology Solution

Applicant Philips Electronics Nederland B.V.

K-Number K192259

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JAK 2019-09-20

syngo.CT Extended Functionality

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192402

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LOX 2019-09-19

Sapphire NC Plus Coronary Dilatation Catheter

Applicant Orbusneich Medical Trading, Inc.

K-Number K192344

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IRP 2019-09-19

ProPerformance Recovery System

Applicant Menlo Brands, LLC

K-Number K192252

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INI 2019-09-19

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

Applicant Eurogreen International, Inc.

K-Number K182631

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JTN 2019-09-19

HardyDisk AST Lefamulin 20µg (LMU20)

Applicant Hardy Diagnostics

K-Number K192326

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KGI 2019-09-19

GEHC DXA Bone Densitometers with enCORE version 18

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K191112

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PML 2019-09-19

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

Applicant CarboFix Orthopedics , Ltd.

K-Number K190526

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IYN 2019-09-19

RS80 EVO Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K192030

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MQL 2019-09-18

GM501 Mineral Oil

Applicant Hamilton Thorne, Inc.

K-Number K191552

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MAX 2019-09-18

HEDRON Lumbar Spacers

Applicant Globus Medical, Inc.

K-Number K191391

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