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

GEX 2017-12-13

2940 nm Er:Yag Laser Handpiece

Applicant Quanta System Spa

K-Number K173002

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PSZ 2017-12-13

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K173502

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FED 2017-12-13

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath

Applicant Cook Incorporated

K-Number K172217

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EIH 2017-12-13

Prodigio Stain Powder

Applicant Operart, LLC

K-Number K171167

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GXY 2017-12-13

Adhesive Electrodes

Applicant Shenzhen Quality Medical Technology Co.,Ltd

K-Number K171381

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OQG 2017-12-13

FMP Extended Liners

Applicant Encore Medical L.P.

K-Number K172651

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OZT 2017-12-13

True Flow Valvuloplasty Perfusion Catheter

Applicant C.R. Bard, Inc.

K-Number K172932

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PHX 2017-12-13

Medacta Shoulder System: Threaded Glenoid Baseplate

Applicant Medacta International S.A.

K-Number K171058

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IYO 2017-12-13

InnoSight Diagnostic Ultrasound System

Applicant Qisda Corporation

K-Number K172056

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KDI 2017-12-13

SAM CRRT Unit, SAM Cassette CRRT

Applicant Spectral Medical, Inc.

K-Number K170790

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GWQ 2017-12-13

eVox System

Applicant Evoke Neuroscience, Inc.

K-Number K171781

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NHA 2017-12-13

TSV BellaTek Encode Healing Abutments

Applicant Biomet 3i

K-Number K173374

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