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

KJJ 2024-08-27

Sealer Solvent

Applicant Inter-Med, Inc.

K-Number K241354

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NHA 2024-08-26

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K240982

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IZQ 2024-08-26

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K-Number K241850

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PKL 2024-08-26

BARS Set (100.60)

Applicant Ovesco Endoscopy AG

K-Number K241858

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LNH 2024-08-26

MyoStrain (6.0)

Applicant Myocardial Solutions, Inc.

K-Number K241607

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FXX 2024-08-26

PRIMED Surgical Masks and PRIMED Procedure Masks

Applicant Primed Medical Products, Inc.

K-Number K240286

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GEI 2024-08-26

FiAPC plus probes

Applicant Erbe Elektromedizin GmbH

K-Number K242044

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QJI 2024-08-26

SmartAdjust Technology

Applicant Insulet Corporation

K-Number K241777

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DQY 2024-08-26

TriClip Steerable Guide Catheter

Applicant ABBOTT MEDICAL

K-Number K241538

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GEX 2024-08-23

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Applicant Olympus Surgical Technologies America

K-Number K242191

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QVF 2024-08-23

SCoV-2 Ag Detect Rapid Test

Applicant InBios International, Inc.

K-Number K233358

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LZA 2024-08-23

Cardinal Health Nitrile Exam Gloves

Applicant Cardinal Health200, LLC

K-Number K241780

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