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

LNH 2023-12-18

MAGNETOM Cima.X

Applicant Siemens Medical Solutions USA, Inc.

K-Number K231587

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QSZ 2023-12-18

SiOxD Wound Matrix

Applicant Sioxmed, LLC

K-Number K232847

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QEW 2023-12-18

ClotTriever Sheath

Applicant Inari Medical, Inc.

K-Number K233815

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KNT 2023-12-18

AMT G-Tube Balloon Gastrostomy Feeding Device

Applicant Applied Medical Technology, Inc.

K-Number K222846

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DYB 2023-12-17

FlexCath Cross Transseptal Solution

Applicant Acutus Medical, Inc.

K-Number K233691

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IRP 2023-12-16

Air Compression Recovery System

Applicant Shenzhen Dongjilian Medical Tech Co., Ltd.

K-Number K233536

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HSB 2023-12-15

Precice Max System

Applicant Nuvasive Specialized Orthopedics, Incorporated

K-Number K232267

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DQA 2023-12-15

Masimo Stork

Applicant Masimo Corporation

K-Number K223721

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OVY 2023-12-15

VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE

Applicant STERIS Corporation

K-Number K233682

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QDG 2023-12-15

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

Applicant Fluoptics Sas (A Getinge Group Company)

K-Number K233564

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LYR 2023-12-15

Hp Detect™ Stool Antigen ELISA

Applicant Biomerica, Inc.

K-Number K232892

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MUJ 2023-12-15

Panther TPS

Applicant Prowess, Inc.

K-Number K231825

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