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

LIT 2023-03-22

Arise™ UHP Dilatation Catheter

Applicant Creagh Medical, Ltd.

K-Number K230191

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GCJ 2023-03-22

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar

Applicant Taiwan Surgical Corporation

K-Number K223593

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NHA 2023-03-22

CEREC Tessera Abutment Block, CEREC Tessera Abutment System

Applicant Dentsply Sirona, Inc.

K-Number K221402

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MBI 2023-03-22

Stativ® Knotted UHMWPE Suture Anchor

Applicant Healthium Medtech Limited

K-Number K223889

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LYA 2023-03-22

Epi-Stop Nasal Gel/epistaxis pack

Applicant Biomed Ent, Inc.

K-Number K230142

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OVE 2023-03-22

SPIRA®-C Integrated Fixation System

Applicant Camber Spine Technologies

K-Number K223837

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GXY 2023-03-22

Ceribell Instant EEG Headcap

Applicant Ceribell, Inc.

K-Number K223086

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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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