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

DTK 2024-07-31

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System

Applicant B.Braun Medical, Inc.

K-Number K240578

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QKZ 2024-07-31

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

Applicant Anx Robotica Corp

K-Number K241934

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OZT 2024-07-31

ValvuloPro Valvuloplasty Balloon Catheter

Applicant Dongguan TT Medical, Inc.

K-Number K240967

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KIF 2024-07-30

Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +

Applicant Shiva Products

K-Number K240446

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GQG 2024-07-30

Nano-Check RSV Test

Applicant Nano-Ditech Corporation

K-Number K240280

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EHD 2024-07-30

WERAY

Applicant Picopack Co., Ltd.

K-Number K241963

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NHA 2024-07-30

SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment

Applicant BioHorizons Implant Systems, Inc.

K-Number K240531

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HRS 2024-07-30

Activmotion S

Applicant Newclip Technics

K-Number K241539

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MAX 2024-07-29

Solar Lumbar Interbody Fusion System

Applicant Degen Medical, Inc.

K-Number K240326

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OWW 2024-07-29

BioBrace® Reinforced Implant

Applicant Conmed Corporation

K-Number K241906

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PZX 2024-07-29

AtriClip FLEX-Mini LAA Exclusion System (ACHM)

Applicant AtriCure, Inc.

K-Number K234125

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OUR 2024-07-29

ARx® SAI Implant System

Applicant Life Spine, Inc.

K-Number K241464

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