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

ODP 2019-02-11

Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device

Applicant Titan Spine, Inc.

K-Number K183557

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QAJ 2019-02-11

Elitone Device

Applicant Elidah, Inc.

K-Number K183585

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FDX 2019-02-08

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

Applicant Wilson-Cook Medical, Inc.

K-Number K181317

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MQB 2019-02-08

Carestream DRX-1 System with DRX Plus 2530 Detectors

Applicant Carestream Health, Inc.

K-Number K183245

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MOS 2019-02-08

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K183186

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CCK 2019-02-08

Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line

Applicant Oridion Medical 1987 , Ltd.

K-Number K181467

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DXH 2019-02-08

Coala Heart Monitor

Applicant Coala Life AB

K-Number K182040

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HKX 2019-02-08

Keeler TonoCare Tonometer

Applicant Keeler Instruments, Inc.

K-Number K181143

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EIH 2019-02-08

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer

Applicant The Argen Corporation

K-Number K182833

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LDP 2019-02-08

SEKURE Acetaminophen L3K Assay

Applicant Sekisui Diagnostics P.E.I., Inc.

K-Number K180835

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JIF 2019-02-08

Ammonia II

Applicant Roche Diagnostics Operations (Rdo)

K-Number K183517

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LZO 2019-02-08

LINK MP Monoblock Hip Prosthesis

Applicant Waldemar Link GmbH & Co. KG

K-Number K183141

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