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

FLE 2022-12-16

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

Applicant Tuttnauer , Ltd.

K-Number K222608

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KDI 2022-12-16

multiFiltratePRO System

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K220281

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QKW 2022-12-16

Tornier Pyrocarbon Humeral Head

Applicant Tornier S.A.S.

K-Number DEN220012

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JSM 2022-12-16

Copan FecalSwab Collection, Transport and Preservation System

Applicant Copan Italia Spa

K-Number K220052

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NQD 2022-12-16

CardioPhase® hsCRP

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K212559

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HWC 2022-12-16

Phantom Metatarsal Shortening System

Applicant Paragon 28, Inc.

K-Number K223184

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OHV 2022-12-16

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K223237

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MAX 2022-12-16

Hexanium PLIF

Applicant Spinevision, S.A.S.

K-Number K223251

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FMI 2022-12-16

Sterile Hypodermic Needles for Single Use

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K223334

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HWC 2022-12-16

BRM TOOL Screws, BIOPLAN Subtalar Implant

Applicant Brm Extremities

K-Number K222820

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MQF 2022-12-16

Daylily Single Use Sterile Embryo Transfer Catheter

Applicant Shanghai Horizon Medical Technology Co., Ltd.

K-Number K220010

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SBF 2022-12-16

Caduceus S

Applicant Taiwan Main Orthopaedic Biotechnology Co., Ltd.

K-Number K220554

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