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

MBI 2023-03-22

Tigon Medical Gryphon Anchor Line

Applicant Tigon Medical

K-Number K220464

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QVR 2023-03-22

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

Applicant Biofire Defense, LLC

K-Number K213362

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GEI 2023-03-22

HF Surgery Generator 400KHZ

Applicant Richard Wolf Medical Instruments Corporation

K-Number K230194

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DSH 2023-03-22

CardioSTAT® ECG Test Solution

Applicant Icentia, Inc.

K-Number K223049

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QIH 2023-03-22

MPXA-2000

Applicant Medipixel, Inc.

K-Number K222036

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PGY 2023-03-21

Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)

Applicant Barco N.V.

K-Number K230520

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JWH 2023-03-21

LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface

Applicant Waldemar Link GmbH & Co. KG

K-Number K230471

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GEI 2023-03-21

Retraction, CWM-910T, APOLEX Tite

Applicant Chungwoo Co., Ltd.

K-Number K222709

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LLZ 2023-03-21

FlightPlan for Embolization

Applicant GE Medical Systems SCS

K-Number K223490

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MQV 2023-03-21

DSM Biomedical Calcium Phosphate Cement

Applicant Dsm Biomedical

K-Number K230054

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LLZ 2023-03-21

Syngo Carbon Space VA30A

Applicant Siemens Healthcare GmbH

K-Number K230561

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KCT 2023-03-21

Instrument Case P1340904

Applicant Cochlear

K-Number K223672

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