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

JAA 2023-10-19

CombiDiagnost R90

Applicant Philips Medical Systems Dmc GmbH

K-Number K232910

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NFO 2023-10-19

C.C. Life 21

Applicant 21 Equipment S.R.L.

K-Number K230459

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ODP 2023-10-19

Acro Composites Interbody System

Applicant Acro Composites, LLC

K-Number K230478

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CAW 2023-10-18

Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K-Number K230702

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NRY 2023-10-18

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Applicant Perfuze, Ltd.

K-Number K232524

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OQB 2023-10-18

OptiMesh Multiplanar Expandable Interbody Fusion System

Applicant Spineology, Inc.

K-Number K231781

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FTL 2023-10-18

T-Line® Hernia Mesh

Applicant Deep Blue Medical Advances, Inc.

K-Number K232924

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MEG 2023-10-18

Medline Safety Insulin and TB Syringes

Applicant Medline Industries, LP

K-Number K231907

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DZE 2023-10-18

INNO SLA Submerged Narrow Implant System

Applicant Cowellmedi Co., Ltd.

K-Number K231395

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QFG 2023-10-18

Omnipod 5 ACE Pump

Applicant Insulet Corporation

K-Number K231826

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KTT 2023-10-18

Arthrex Small External Fixation System

Applicant Arthrex, Inc.

K-Number K232897

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LLZ 2023-10-18

EConsole1

Applicant DRTECH Corporation

K-Number K231225

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