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

IYN 2016-09-06

ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K162243

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IYN 2016-09-06

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

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

K-Number K162267

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JOS 2016-09-06

Resection Electrodes

Applicant Olympus Winter & Ibe GmbH

K-Number K161600

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LZC 2016-09-06

HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves

Applicant Halyard Health

K-Number K160709

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CBK 2016-09-06

HAMILTON-MR1

Applicant Hamilton Medical AG

K-Number K153046

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NKG 2016-09-06

Xenco Medical Posterior Cervical System

Applicant Xenco Medical, LLC

K-Number K161478

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MAX 2016-09-06

Nanovis Intervertebral Body Fusion System and Forticore(R)

Applicant Nanovis, LLC

K-Number K161485

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NUC 2016-09-06

Mano and Mano Personal Lubricant

Applicant Mano and Mano Proprietary Limited

K-Number K161585

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OWB 2016-09-05

SyncVision System

Applicant Volcano Corporation

K-Number K161756

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DQK 2016-09-03

CardioConfirm

Applicant Mortara Instrument, Inc.

K-Number K161465

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POL 2016-09-02

Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm

Applicant Concentric Medical, Inc.

K-Number DEN150049

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MMX 2016-09-02

Indy OTW Vascular Retriever

Applicant Cook Incorporated

K-Number K160593

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