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

FMI 2019-11-21

SAM IO Intraosseous Access System

Applicant Sam® Medical Products, Inc.

K-Number K191488

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DQX 2019-11-21

Asahi PTCA Guide Wire Asahi SION Series

Applicant Asahi Intecc Co., Ltd.

K-Number K191464

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NJD 2019-11-21

Engage™ Partial Knee System

Applicant Engage Uni, LLC

K-Number K190439

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LFD 2019-11-21

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray

Applicant Oralabs, Inc.

K-Number K181839

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GEI 2019-11-21

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

Applicant Us Medical Innovations, LLC

K-Number K192124

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DQY 2019-11-21

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

Applicant Biotronik, Inc.

K-Number K192996

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JAK 2019-11-21

SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192061

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JXG 2019-11-21

M. Blue Adjustable Shunt System

Applicant Aesculap, Inc.

K-Number K192266

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KRD 2019-11-21

Torpedo Gelatin Foam

Applicant Biosphere Medical, S.A.

K-Number K192480

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MKU 2019-11-21

LZI Cotinine II Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K192299

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HRS 2019-11-21

Axis Plating System

Applicant Extremity Medical, LLC

K-Number K192592

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DQY 2019-11-21

PG Pro Microcatheter

Applicant MicroVention, Inc. A TERUMO Group Company

K-Number K192625

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