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

KPS 2024-05-24

SET-5002

Applicant Shimadzu Corporation Medical Systems Division

K-Number K240827

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KHJ 2024-05-24

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

Applicant Cook Biotech Incorporated

K-Number K232646

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KWQ 2024-05-24

Wolff's Law Anterior Cervical Plate System

Applicant Spinal Simplicity, LLC

K-Number K240592

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OBR 2024-05-24

Anti Grinding Guard

Applicant Xiamen Yizhou Imp. & Exp. Co., Ltd.

K-Number K240810

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OMP 2024-05-24

Renasys Edge

Applicant Smith & Nephew Medical, Ltd.

K-Number K231939

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QFG 2024-05-24

DEKA ACE Pump System

Applicant Deka Research and Development

K-Number K241178

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QIH 2024-05-24

LVivo IQS

Applicant Dia Imaging Analysis, Ltd.

K-Number K240769

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QJI 2024-05-23

CamAPS FX

Applicant Camdiab , Ltd.

K-Number K232603

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OLO 2024-05-23

Drill Guide; Drill Bit; Spine & Trauma Navigation

Applicant Brainlab AG

K-Number K240701

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LLZ 2024-05-23

Syngo Carbon Enterprise Access (VA40A)

Applicant Siemens Healthcare GmbH

K-Number K240294

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ODP 2024-05-23

uCerv Flux™-C 3D Porous Titanium Cervical Interbody

Applicant Ulrich Medical USA, Inc.

K-Number K241396

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OXF 2024-05-23

3DMatrix Surgical Mesh

Applicant Printbio, Inc.

K-Number K232602

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