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

OWN 2017-01-11

SPY Phi Open Field Handheld Fluorescence Imaging System

Applicant Novadaq Technologies, Inc.

K-Number K162885

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GCJ 2017-01-11

U-IGNITE Bladeless Trocar

Applicant Tianjin Uwell Medical Device Manufacturing Co., Ltd.

K-Number K162387

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GEX 2017-01-11

Epic Pro

Applicant Biolase, Inc.

K-Number K163128

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FMF 2017-01-11

ConceptoMed Luer-Jack Slip 10ml

Applicant Conceptomed AS

K-Number K162057

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EBF 2017-01-11

CERAMAGE UP

Applicant Shofu Dental Corporation

K-Number K162261

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FET 2017-01-11

ENDOCAM Flex HD Camera System 5521

Applicant Richard Wolf Medical Instruments Corporation

K-Number K161204

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MUE 2017-01-10

Mammomat Fusion with Stereotactic Biopsy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163252

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IYN 2017-01-10

EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K163120

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HRS 2017-01-10

osteo-WEDGE II ® Open Wedge Bone Locking Plate System

Applicant Graham Medical Technologies, LLC Dba Gramedica

K-Number K162179

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JJY 2017-01-10

Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

Applicant Bio-Rad Laboratories

K-Number K163015

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HTN 2017-01-10

Akros Fibulink Syndesmosis Repair Kit

Applicant Akros Medical

K-Number K162805

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DZL 2017-01-10

Neo GBR System

Applicant Neobiotech Co., Ltd.

K-Number K160991

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