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

LZA 2023-03-30

Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Professional Latex Sdn Bhd

K-Number K220088

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FRO 2023-03-30

BIASURGE Advanced Surgical Solution

Applicant Rochal Technologies, LLC

K-Number K223377

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HRS 2023-03-30

Medartis APTUS® Ulna Plates

Applicant Medartis AG

K-Number K223853

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KRA 2023-03-30

Maestro Microcatheter

Applicant Merit Medical System, Inc.

K-Number K230636

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QRN 2023-03-30

Comfort Marker 2.0

Applicant Medical Precision BV

K-Number K222112

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OBO 2023-03-30

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

Applicant Nidek Co., Ltd.

K-Number K221320

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HRS 2023-03-30

MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System

Applicant Crossroads Extremity Systems, LLC

K-Number K223342

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MQV 2023-03-29

Tactoset

Applicant Anika Therapeutics, Inc.

K-Number K223915

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OUR 2023-03-29

SiJoin®T3

Applicant Vgi Medical, Inc.

K-Number K213815

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KGC 2023-03-29

PUMA-G System

Applicant Coaptech, Inc.

K-Number K223916

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HRS 2023-03-29

WishBone Medical Plate and Screw System

Applicant Wishbone Medical, Inc.

K-Number K230527

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HRS 2023-03-29

KLS Martin Level One Rib Fixation System

Applicant KLS-Martin L.P.

K-Number K222397

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