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

OLO 2019-08-29

Spine & Trauma Navigation

Applicant Brainlab AG

K-Number K183605

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IYN 2019-08-29

Voluson E6, Voluson E8, Voluson E10

Applicant GE Healthcare

K-Number K192159

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CAW 2019-08-29

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity

Applicant Invacare Corporation

K-Number K191159

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MBI 2019-08-29

Dunamis Fixation Button System

Applicant Dunamis, LLC

K-Number K191319

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QSY 2019-08-29

gel-e Flex+

Applicant Gel-E, Inc.

K-Number K182811

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QEW 2019-08-29

ClotTriever Thrombectomy System

Applicant Inari Medical

K-Number K192036

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MQB 2019-08-29

Yushan X-Ray Flat Panel Detector

Applicant Innocare Optoelectronics Corp.

K-Number K191939

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HIH 2019-08-29

Omni Hysteroscope, Omni Lok cervical seal

Applicant Hologic, Inc.

K-Number K191281

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POC 2019-08-29

BD MAX Check-Points CPO

Applicant Check-Points Health B.V.

K-Number K190613

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NPL 2019-08-29

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal

Applicant Geistlich Pharma AG

K-Number K192042

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LRK 2019-08-29

O2Vent Optima

Applicant Oventus Manufacturing Pty, Ltd.

K-Number K190236

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KWQ 2019-08-29

Binary® Anterior Cervical Plate System

Applicant Genesys Spine

K-Number K192076

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