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

MCW 2023-09-27

FreedomFlow Orbital Circumferential Atherectomy System

Applicant Cardio Flow Inc.,

K-Number K231538

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LCP 2023-09-27

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

Applicant Abbott Diagnostics Technologies AS

K-Number K214117

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FGE 2023-09-27

EndoGI S-Path Biliary Stent System

Applicant Endogi Medical, Ltd.

K-Number K232596

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FBK 2023-09-27

Disposable Injection Needle AF series

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K-Number K230925

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NKB 2023-09-27

Invictus® Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K232275

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DYB 2023-09-27

Talon Transseptal Sheath

Applicant Inari Medical, Inc.

K-Number K231108

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DJG 2023-09-27

CEDIA Heroin Metabolite (6-AM) Assay

Applicant Microgenics Corporation

K-Number K231007

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MQV 2023-09-27

Cove Strip, OsteoCove Strip

Applicant SeaSpine Orthopedics Corporation

K-Number K232668

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DRE 2023-09-27

Micro Ace™ Advanced Micro Access System

Applicant Merit Medical Systems, Inc.

K-Number K232609

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KRO 2023-09-27

EVOLUTION® Hinge Knee System

Applicant Microport Orthopedics, Inc.

K-Number K230563

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NJR 2023-09-27

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

Applicant Cepheid

K-Number K222638

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JZO 2023-09-26

Access Thyroglobulin Antibody II

Applicant Beckman Coulter, Inc.

K-Number K213517

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