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

HRS 2023-08-18

Sterile Products of the APTUS System

Applicant Medartis AG

K-Number K232144

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OBO 2023-08-18

P200TE (A10700)

Applicant Optos Plc.

K-Number K231673

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DQK 2023-08-18

Smart Wedge algorithm

Applicant Edwards Lifesciences, LLC

K-Number K230579

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PFO 2023-08-18

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

Applicant Cochlear

K-Number K231204

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KGO 2023-08-18

Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs

Applicant Sentienx Sdn Bhd

K-Number K222993

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HEB 2023-08-18

Daye Tampon

Applicant Annes Daye, Ltd.

K-Number K223883

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FRO 2023-08-18

ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

Applicant Smith & Nephew Medical Limited

K-Number K223526

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PGY 2023-08-18

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K231026

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DRT 2023-08-18

Sleepiz One+

Applicant Sleepiz AG

K-Number K223163

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EBC 2023-08-18

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio

Applicant Ultradent Product, Inc.

K-Number K232498

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CKG 2023-08-18

IDS ACTH II

Applicant Immunodiagnostic Systems Limited

K-Number K223867

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QOF 2023-08-17

Xpert Xpress CoV-2/Flu/RSV plus

Applicant Cepheid®

K-Number K231481

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