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

IZQ 2024-04-19

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

Applicant Ulrich GmbH & Co. KG

K-Number K233737

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KGN 2024-04-19

Miro3D Fibers Wound Matrix

Applicant Reprise Biomedical, Inc.

K-Number K240753

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GZJ 2024-04-19

Electrical Neuromuscular Stimulator, Cure Trio

Applicant Oriental Inspiration Limited

K-Number K233046

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FOZ 2024-04-19

AccuCath Ace™ Intravascular Catheter

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K-Number K233106

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QNP 2024-04-19

SKOUT® system

Applicant Iterative Scopes, Inc.

K-Number K240781

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OVE 2024-04-19

UniSpace® Stand-Alone C Cage

Applicant Innosys Co., Ltd.

K-Number K234119

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MPD 2024-04-19

LIFEPAK® 35 AC Power Adapter (41335-000001)

Applicant Stryker Physio-Control

K-Number K240162

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KGN 2024-04-19

ReyaGel (RG03 - MTP gel 3mL)

Applicant Fettech

K-Number K232204

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QEW 2024-04-19

ICE Aspiration System

Applicant Expanse Medical, Inc.

K-Number K234073

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OUR 2024-04-19

Patriot-SI Posterior Implant System

Applicant Spinal Simplicity, LLC

K-Number K232259

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LFD 2024-04-19

Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)

Applicant Laclede, Inc.

K-Number K240508

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MUH 2024-04-18

RAYSCAN a-Expert

Applicant Ray Co., Ltd.

K-Number K232325

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