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

PJA 2022-10-14

HeartFlow Analysis

Applicant HeartFlow, Inc.

K-Number K213857

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PHX 2022-10-14

Tornier Perform Humeral System Fracture

Applicant Tornier, Inc.

K-Number K220914

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JXG 2022-10-14

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

Applicant Integra Lifesciences Production Corporation

K-Number K221840

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FMI 2022-10-14

Safety Insulin Pen Needles

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K213183

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MAX 2022-10-14

FOCUS Interbody System

Applicant Oc Medical Devices

K-Number K221172

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MAX 2022-10-14

X-Pac Expandable Lumbar Cage System

Applicant Expanding Innovations, Inc.

K-Number K222797

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KOD 2022-10-13

allFlex Ureteral Catheters, Krait Ureteral Catheters

Applicant Allwin Medical Devices, Inc.

K-Number K220730

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PKP 2022-10-13

SCIg60 Infusion System

Applicant Emed Technologies Corporation

K-Number K222087

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DZE 2022-10-13

IM/ST Fixture System

Applicant Guilin Fiteeth Medical Instrument Co., Ltd.

K-Number K212702

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ONG 2022-10-13

Fiber Laser Treatment System

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K221770

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LON 2022-10-13

VITEK 2 AST-Gram Positive Cefoxitin Screen

Applicant bioMerieux, Inc.

K-Number K220805

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DYB 2022-10-13

Abiomed 14Fr Low Profile Introducer Set

Applicant Abiomed, Inc.

K-Number K222113

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