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

NBL 2024-05-01

SmarTooth

Applicant Smartooth Co., Ltd.

K-Number K231722

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HKY 2024-05-01

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

Applicant Reichert, Inc.

K-Number K233516

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FGA 2024-05-01

Percutaneous Nephroscope System

Applicant Karl Storz SE & CO. KG

K-Number K232370

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DXF 2024-05-01

HOTWIRE RF Guidewire

Applicant Atraverse Medical

K-Number K240900

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EOQ 2024-05-01

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K234113

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IRP 2024-05-01

Cold Compression

Applicant Jkh Health Co., Ltd.

K-Number K240986

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DYB 2024-05-01

AuST Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K240829

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GEX 2024-04-30

Picosecond Nd:YAG Laser System

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K240118

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IYE 2024-04-30

Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)

Applicant Varian Medical Systems, Inc.

K-Number K232923

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GWQ 2024-04-30

Flexset System

Applicant Zeto, Inc.

K-Number K233403

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MQV 2024-04-30

Morpheus® Moldable; Agilon® Moldable

Applicant Biogennix, LLC

K-Number K240621

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EFB 2024-04-30

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)

Applicant Litu Tech , Ltd.

K-Number K233122

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