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

NFO 2023-04-27

Myolift QT

Applicant Johari Digital Healthcare Limited

K-Number K213078

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OHT 2023-04-27

Braun Skin i.expert

Applicant Cyden Limited

K-Number K230911

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GEI 2023-04-27

PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter

Applicant Conmed Corporation

K-Number K230547

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LZA 2023-04-27

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K221983

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JWH 2023-04-27

Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert

Applicant Conformis, Inc.

K-Number K230844

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GWQ 2023-04-27

Cumulus Functional Neurophysiology Platform

Applicant Cumulus Neuroscience Limited

K-Number K221963

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QEW 2023-04-27

ClotTriever XL Catheter

Applicant Inari Medical, Inc.

K-Number K223210

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KPS 2023-04-27

Precision DL

Applicant GE Healthcare

K-Number K223212

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NTE 2023-04-27

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

Applicant MicroVention, Inc.

K-Number K222694

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HRS 2023-04-27

PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

Applicant Stryker GmbH

K-Number K222381

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HIH 2023-04-27

UNIDRIVE SIII System

Applicant Karl Storz-Endoscopy-America, Inc.

K-Number K223520

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PGW 2023-04-27

ENT EM

Applicant Brainlab AG

K-Number K223734

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