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

KPR 2024-07-26

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)

Applicant DRTECH Corporation

K-Number K233530

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QMA 2024-07-26

Cell-Free DNA BCT

Applicant Streck, Inc.

K-Number K231776

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MNR 2024-07-26

LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)

Applicant Largan Medical Co., Ltd.

K-Number K233501

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MMI 2024-07-25

Atellica® IM High-Sensitivity Troponin I (TnIH)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K241165

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OLO 2024-07-25

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

Applicant Stryker Leibinger GmbH & Co KG

K-Number K241171

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FGB 2024-07-25

KARL STORZ Fiber Telescopes for Urology

Applicant Karl Storz SE & CO. KG

K-Number K233372

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PLV 2024-07-25

Navident

Applicant Claronav, Inc.

K-Number K233563

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GCJ 2024-07-25

Arthrex Synergy Vision Endoscopic Imaging System

Applicant Arthrex, Inc.

K-Number K241361

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OHS 2024-07-25

PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)

Applicant Dongguan Hunter Electronic Technology Co., Ltd.

K-Number K241203

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MBI 2024-07-25

Grappler Interference Screw System

Applicant Paragon 28, Inc.

K-Number K241864

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HIG 2024-07-25

Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

Applicant Hologic, Inc.

K-Number K240886

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QNP 2024-07-25

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K241887

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