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

PGW 2020-01-30

TruDi Navigation System

Applicant Biosense Webster

K-Number K192397

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OMA 2020-01-30

Neo

Applicant Eemagine Medical Imaging Solutions GmbH

K-Number K192889

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JWH 2020-01-30

ATTUNE All-Polyethylene Tibia

Applicant Depuy Ireland UC

K-Number K193057

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HIF 2020-01-30

GTK Veress Needles

Applicant Guangzhou T.K Medical Instrument Co., Ltd.

K-Number K193339

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HSN 2020-01-29

Quantum® Total Ankle Prosthesis

Applicant In2bones Sas

K-Number K191380

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MWI 2020-01-29

WVSM (Wireless Vital Signs Monitor) RWC + miniCap

Applicant Athena Gtx

K-Number K191989

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QDK 2020-01-29

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K193642

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MHX 2020-01-29

Carescape B850

Applicant GE Healthcare Finland Oy

K-Number K191323

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EBI 2020-01-29

VITA VIONIC Bond

Applicant Vita Zanhnfabrik H. Rauter GmbH Co.

K-Number K191926

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LJE 2020-01-29

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

Applicant Cook Incorporated

K-Number K191498

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FCG 2020-01-29

Biopsy Needle

Applicant Ushare Medical, Inc.

K-Number K191472

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NHA 2020-01-29

TruAbutment DS

Applicant Truabutment, Inc.

K-Number K183106

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