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

EOB 2020-01-27

CMOS Video Rhino-Laryngoscope SSU

Applicant Karl Storz SE & CO. KG

K-Number K192090

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GCJ 2020-01-27

Xenocor Articulating Xenoscope Laparoscope

Applicant Xenocor, Inc.

K-Number K193315

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KPS 2020-01-26

Emission Computed Tomography System

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K193241

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IYO 2020-01-26

THD Procto Software System

Applicant Thd Spa

K-Number K193512

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GYC 2020-01-25

Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

Applicant Ad-Tech Medical Instrument Corporation

K-Number K191186

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CHL 2020-01-24

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K193246

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MUJ 2020-01-24

MRCAT brain

Applicant Philips Medical Systems MR Finland

K-Number K193109

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HRS 2020-01-24

APTUS Clavicle System

Applicant Medartis AG

K-Number K192984

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FRG 2020-01-24

Gemini Titan Sterilization Wrap

Applicant Medline Industries, Inc.

K-Number K192641

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NLH 2020-01-24

Reprocessed Achieve Catheter Connecting Cable

Applicant Innovative Health, LLC

K-Number K193263

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OWN 2020-01-24

Cellvizio 100 Series System with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K191144

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NKG 2020-01-24

SYPMHONY OCT System

Applicant Medos International SARL

K-Number K192014

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