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

NHA 2024-08-20

TDS (TECHWIN DENTAL SYSTEM)

Applicant Techwin Co., Ltd.

K-Number K231932

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OHS 2024-08-20

Luna 4 plus

Applicant Foreo, Inc.

K-Number K241102

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LNH 2024-08-20

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K241496

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MPN 2024-08-20

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

Applicant Okapi Medical, LLC Dba Resivant Medical

K-Number K234114

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JOJ 2024-08-20

CELERITY HP Indicator Tape (PCC077)

Applicant Steris

K-Number K242189

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FLL 2024-08-20

Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)

Applicant Covidien

K-Number K240077

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PZP 2024-08-20

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

Applicant Procept Biorobotics

K-Number K240200

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OWN 2024-08-19

Histolog® Scanner (Hardware 2.4, Software 3.3)

Applicant Samantree Medical SA

K-Number K241275

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OMP 2024-08-19

Negative Pressure Wound Therapy Device (V-Move, V-Grand)

Applicant Med Way, Inc.

K-Number K241023

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DZI 2024-08-19

MT-Bone

Applicant Mectron S.P.A.

K-Number K242432

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OUR 2024-08-19

iFuse TORQ TNT™ Implant System

Applicant SI-BONE, Inc.

K-Number K241504

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HRS 2024-08-19

RibFix Titan™ Fixation System

Applicant Riverpoint Medical

K-Number K241282

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