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

LRK 2022-12-02

SilentZPro 2.0

Applicant Shinrin-Yoku Traders, LLC

K-Number K220688

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DPS 2022-12-02

PageWriter TC35 Cardiograph

Applicant Medizin Systeme Boblingen GmbH

K-Number K221141

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GEH 2022-12-02

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

Applicant STERIS Corporation

K-Number K223369

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FMI 2022-12-02

DropSafeTM SicuraTM

Applicant Pikdare Spa

K-Number K223353

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FTL 2022-12-02

Parietene Macroporous Mesh

Applicant Sofradim Production

K-Number K223218

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JAK 2022-12-02

CardioGraphe

Applicant Arineta , Ltd.

K-Number K213465

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NHA 2022-12-02

CreoDent Solidex Customized Abutment and Screw

Applicant Creodent Prosthetics, Ltd.

K-Number K220390

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EZD 2022-12-02

Self-Cath and Self-Cath Plus

Applicant Coloplast

K-Number K221401

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FQO 2022-12-02

Maestro Platform

Applicant Moon Surgical

K-Number K221410

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NEZ 2022-12-02

NaviCam Small Bowel Capsule Endoscopy System

Applicant Ankon Technologies Co., Ltd.

K-Number K221590

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PHX 2022-12-02

INHANCETM Shoulder System Humeral Stems and Stemless

Applicant Depuy Ireland UC

K-Number K223211

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CBI 2022-12-01

Chartis Precision Catheter

Applicant Pulmonx Corporation

K-Number K222340

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