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

NUH 2024-06-27

TENS&EMS units (SM9109A, SM9109B)

Applicant Plexus Yoga, LLC Dba Chirp

K-Number K241509

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SBP 2024-06-27

Xpert HCV; GeneXpert Xpress System

Applicant Cepheid

K-Number DEN240016

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HGX 2024-06-27

Annabella Double Breast Pump (ADO-US23-1000)

Applicant Annabella Tech

K-Number K241506

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FED 2024-06-27

Pathfinder® CR System

Applicant Neptune Medical, Inc.

K-Number K240853

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MQV 2024-06-27

MagnetOs Easypack Putty

Applicant Kuros Biosciences

K-Number K241212

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FRC 2024-06-27

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)

Applicant 3M Company

K-Number K241542

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MLR 2024-06-27

SteroScope® Sterilization Technology System

Applicant Ideate Medical, Inc.

K-Number K233762

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MCW 2024-06-27

Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

Applicant Eximo Medical, Ltd.

K-Number K241553

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JWH 2024-06-27

UNIKO PointCloud Knee Instruments

Applicant Unik Orthopedics, Inc.

K-Number K240327

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CBK 2024-06-27

Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask

Applicant Sleepnet Corporation

K-Number K241520

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PLA 2024-06-27

EsoCool Thermal Regulation Catheter

Applicant Nuvaira, Inc.

K-Number K233357

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EBF 2024-06-27

els extra low shrinkage® composite & els extra low shrinkage® flow

Applicant Saremco Dental AG

K-Number K240823

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