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

LJX 2023-06-16

Healgen URS Test Strips

Applicant Healgen Scientific,, LLC

K-Number K231045

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IOR 2023-06-16

Manual Wheelchair (A006)

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K231110

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NGX 2023-06-16

Fitness Belt (Model: KLT-07)

Applicant Shenzhen Kelutongda Industrial Co., Ltd.

K-Number K231136

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HQD 2023-06-16

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K230965

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KTT 2023-06-16

Smart Correction System (HA Half Pins)

Applicant Wishbone Medical, Inc.

K-Number K231461

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DQA 2023-06-16

BabySat 3

Applicant Owlet Babycare, Inc.

K-Number K222597

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QIH 2023-06-16

IB Lab LAMA

Applicant Ib Lab GmbH

K-Number K223646

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CBK 2023-06-16

Mindray SV600 Ventilator, Mindray SV800 Ventilator

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K220107

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PIB 2023-06-16

EyeArt v2.2.0

Applicant Eyenuk, Inc.

K-Number K223357

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MRZ 2023-06-15

UTC 3mL Medication Cartridge

Applicant Gilero, LLC

K-Number K230718

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FQH 2023-06-15

ERBEJET® 2 System

Applicant Erbe Elektromedizin GmbH

K-Number K231023

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LZO 2023-06-15

Xerxes Hip Stem

Applicant Xerxes Arthopedix, LLC

K-Number K231109

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