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

EIH 2024-07-09

Zirconia Block

Applicant Hunan Hualian Special Ceramics Co., Ltd.

K-Number K241316

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OHT 2024-07-09

IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)

Applicant Shenzhen Lescolton Electrical Appliance Co., Ltd.

K-Number K241343

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MAX 2024-07-09

aprevo® TLIF-C Articulating System

Applicant Carlsmed

K-Number K241019

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EKX 2024-07-09

EM-07 Cordless Endo Motor

Applicant Forum Engineering Technologies (96) , Ltd.

K-Number K232551

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QYX 2024-07-08

RhythmStar System

Applicant RhythMedix, LLC

K-Number K233584

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GEX 2024-07-08

LED Light Therapy Device, ELIXIR MD™

Applicant Yassen Wellness, LLC

K-Number K241293

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NAY 2024-07-08

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K240502

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EHD 2024-07-05

LifeRay Intraoral Handheld X-ray System

Applicant Lucas Lifecare

K-Number K241305

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JOJ 2024-07-05

STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)

Applicant Advanced Sterilization Products, Inc.

K-Number K234084

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IOR 2024-07-05

Merlexi Craft Bariatric series of manual wheelchairs

Applicant Turbo Wheelchair Co., Inc.

K-Number K240120

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MLR 2024-07-05

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

Applicant Advanced Sterilization Products

K-Number K234082

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GKZ 2024-07-05

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

Applicant Beckman Coulter, Inc.

K-Number K240252

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