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

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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IYN 2017-12-13

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System

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

K-Number K173369

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EBG 2017-12-13

Fixtemp C&B

Applicant Dreve Dentamid GmbH

K-Number K171729

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LZA 2017-12-12

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)

Applicant Hartalega Sdn Bhd

K-Number K173137

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PII 2017-12-12

T2Candida 1.1 Panel

Applicant T2biosystems, Inc.

K-Number K173536

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LLZ 2017-12-12

Advanced Diffusion Analysis (ADA) application

Applicant Philips Medical Systems Nederland B.V.

K-Number K173467

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