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

HAW 2025-01-28

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

Applicant Brainlab AG

K-Number K243698

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MBI 2025-01-28

Argo Knotless GENESYS Anchor

Applicant Conmed Corporation

K-Number K244025

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OHS 2025-01-28

LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)

Applicant Shenzhen Rainbow Technology Co., Ltd.

K-Number K243423

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FRC 2025-01-28

3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

Applicant 3M Company

K-Number K243501

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LCO 2025-01-28

HemosIL CL HIT-IgG(PF4-H)

Applicant Instrumentation Laboratory (IL) Co.

K-Number K243374

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GEX 2025-01-27

CO2 Laser Therapy Systems (SHE-LSP003-1)

Applicant Beijing Sano Laser S&T Development Co.,Ltd

K-Number K242941

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JAK 2025-01-27

Bunkerhill AVC

Applicant BunkerHill Health

K-Number K243229

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KPS 2025-01-27

Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

Applicant Raysolution Healthcare Co., Ltd.

K-Number K241266

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EIA 2025-01-27

Firstar Dental Unit

Applicant Firstar Dental Company

K-Number K231297

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SAQ 2025-01-27

Symani Surgical System (820-03830)

Applicant Medical Microinstruments, Inc.

K-Number K250014

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KDL 2025-01-24

OrganProtex HTK Solution

Applicant Bridge TO Life, Ltd.

K-Number K241239

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QPN 2025-01-24

Galen™ Second Read™

Applicant Ibex Medical Analytics , Ltd.

K-Number K241232

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