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

QER 2019-01-10

CLARUS

Applicant Carl Zeiss Meditec, Inc.

K-Number K181444

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FLL 2019-01-10

Infrared Ear Thermometer

Applicant Hetaida Technology Co., Ltd.

K-Number K180387

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HRS 2019-01-10

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates

Applicant Additive Orthopaedics

K-Number K183011

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CAW 2019-01-10

CONTEC Oxygen Concentrator

Applicant Contec Medical System Co., Ltd.

K-Number K180837

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EZL 2019-01-10

Signal Catheter

Applicant Safe Medical Design

K-Number K182635

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MWP 2019-01-10

Trident HD Specimen Radiography System

Applicant Hologic, Inc.

K-Number K182727

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LLZ 2019-01-09

MRCP+ v1.0

Applicant Perspectum Diagnostics, Ltd.

K-Number K183133

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MUW 2019-01-09

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

Applicant C&E GP Specialist, Inc.

K-Number K183200

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LOD 2019-01-09

G3A 40 Bone Cement

Applicant G21, S.R.L.

K-Number K181282

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IYN 2019-01-09

DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K181637

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MQB 2019-01-09

Wireless Digital Flat Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K183713

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OVD 2019-01-09

Reliance Lumbar IBF System

Applicant Reliance Medical Systems

K-Number K181118

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