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

GCJ 2020-06-22

O-Mec 690 Series Laparoscopes

Applicant Omec Medical, Inc.

K-Number K201151

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OBJ 2020-06-22

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Applicant Northeast Scientific, Inc.

K-Number K200195

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OAS 2020-06-22

Axeos

Applicant Dentsply Sirona

K-Number K201140

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OHS 2020-06-22

Opera Lebody (Gold), Opera Lebody (Zafiro)

Applicant Gtg Wellness Co., Ltd.

K-Number K201107

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DSA 2020-06-22

Patient Monitoring Cable (SpO2 Extension Cable)

Applicant Shenzhen Coreray Technology, Ltd.

K-Number K192404

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PLL 2020-06-20

EverLift Submucosal Lifting Agent

Applicant Gi Supply

K-Number K191923

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HWC 2020-06-20

InFrame Cannulated Fixation System

Applicant Exsomed Corp.

K-Number K201430

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IZL 2020-06-19

AQUILA 320 D / AQUILA 320 S

Applicant Vmi Tecnologias Ltda

K-Number K201340

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KLW 2020-06-19

Multiflex Tinnitus Technology

Applicant Starkey Laboratories, Inc.

K-Number K201370

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PHL 2020-06-19

EksoNR

Applicant Ekso Bionics, Inc.

K-Number K200574

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DTR 2020-06-19

MPS 3 Myocardial Protection System

Applicant Quest Medical, Inc.

K-Number K200438

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FLE 2020-06-19

STATClave G4 Chamber Autoclave

Applicant Scican , Ltd.

K-Number K192910

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