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

NEW 2019-01-10

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices

Applicant ETHICON, Inc.

K-Number K182873

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NUH 2019-01-10

Maxpower Relief

Applicant Omron Healthcare, Inc.

K-Number K182120

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IYN 2019-01-10

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

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

K-Number K182636

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PLR 2019-01-10

VLIFT-s Vertebral Body Replacement System

Applicant Stryker Spine

K-Number K183071

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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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