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

LLL 2016-02-12

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

Applicant Inova Diagnostics, Inc.

K-Number K151429

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GAT 2016-02-12

HS SutureTape

Applicant Riverpoint Medical

K-Number K153307

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LZA 2016-02-12

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Suqian Xingye Glove Co,Ltd

K-Number K151680

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GEX 2016-02-12

Tranberg CLS Laser Fiber

Applicant Clinical Laserthermia Systems, AB

K-Number K151569

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FGE 2016-02-12

X-Suit NIR Biliary Metallic Stent

Applicant Medinol, Ltd.

K-Number K150487

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LRC 2016-02-12

Relieva Scout Multi-Sinus Dilation System

Applicant Acclarent, Inc.

K-Number K153341

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LLZ 2016-02-12

TraumaCad Mobile Release 2.0

Applicant Voyant Health, Ltd.

K-Number K160001

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HWC 2016-02-12

MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

Applicant Merete Medical GmbH

K-Number K152187

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DPS 2016-02-12

Digital Electrocardiograph

Applicant Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

K-Number K160092

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NKB 2016-02-12

Adena-Zina System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K152781

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MWI 2016-02-12

Masimo Root Vital Signs Monitoring System and Accessories

Applicant Masimo Corporation

K-Number K151644

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JAK 2016-02-12

Clear Guide SCENERGY

Applicant Clear Guide Medical

K-Number K153004

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