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

JXG 2023-10-19

IRRAflow Active Fluid Exchange System (AFES)

Applicant Irras USA, Inc.

K-Number K231664

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PQA 2023-10-19

Xpert Xpress MVP; GeneXpert Xpress System

Applicant Cepheid

K-Number K231381

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BZD 2023-10-19

Oran Park Mask

Applicant Resmed Pty Ltd (Registration Number: 3004604967)

K-Number K230476

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JDR 2023-10-19

Medline UNITE® REFLEX® Nitinol Staple Kit

Applicant Medline Industries, LP

K-Number K232905

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PEK 2023-10-19

KeyLift Expandable Interlaminar Stabilization System

Applicant Flospine

K-Number K232484

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LZO 2023-10-19

Actinia® hip stems

Applicant Implantcast GmbH

K-Number K232371

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GEI 2023-10-19

Radio Frequency System

Applicant Shenzhenshi Sincoheren S&T Development Co., Ltd.

K-Number K231749

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OVE 2023-10-19

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System

Applicant Life Spine, Inc.

K-Number K231704

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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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