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

FJK 2023-05-31

CombiSet Hemodialysis Blood Tubing Set

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K213992

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LNH 2023-05-30

Sonic DL

Applicant Ge Medical Systems,Llc (Ge Healthcare)

K-Number K223523

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DSA 2023-05-30

RFP-100A Connector Cable (Single Use)

Applicant Baylis Medical Technologies, Inc.

K-Number K230571

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QQI 2023-05-30

PrecisionTAVI (v1.1)

Applicant Dasi Simulations

K-Number K223809

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LLZ 2023-05-30

Quicktome Software Suite

Applicant Omniscient Neurotechnology Pty Ltd (O8t)

K-Number K222359

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HRS 2023-05-30

Smith & Nephew ACCORD Cable System

Applicant Smith & Nephew

K-Number K223762

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GEH 2023-05-30

Hydrozid Precise

Applicant Bibawo Medical A/S

K-Number K221897

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FCG 2023-05-30

EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)

Applicant Cook Ireland, Ltd.

K-Number K230909

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QEW 2023-05-30

Excipio SV Aspiration Catheter and Tubing

Applicant Contego Medical, Inc.

K-Number K230030

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LZA 2023-05-30

First Glove Blue Nitrile Examination Gloves Powder Free

Applicant First Glove Sdn. Bhd.

K-Number K230958

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PBF 2023-05-30

MyPAO Guides

Applicant Medacta International S.A.

K-Number K220706

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FMT 2023-05-30

Babyroo TN300

Applicant Draeger Medical Systems, Inc.

K-Number K230278

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