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

NKB 2023-12-12

ARx MIS Spinal Screw System

Applicant Life Spine, Inc.

K-Number K233455

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MAX 2023-12-12

Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K230872

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FGB 2023-12-12

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection

Applicant Boston Scientific Corporation -

K-Number K233645

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LLZ 2023-12-12

TeleScan

Applicant Bb Imaging

K-Number K233634

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QZF 2023-12-12

NaviCam ProScan

Applicant Ankon Technologies Co., Ltd.

K-Number DEN230027

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GEI 2023-12-12

SIRA RFA Electrosurgical Device

Applicant Innoblative Designs, Inc.

K-Number K232947

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OWB 2023-12-12

Ziehm Solo FD

Applicant Ziehm Imaging GmbH

K-Number K231669

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DYB 2023-12-12

Intri24 Introducer Sheath (52-101)

Applicant Inari Medical, Inc.

K-Number K233646

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QIH 2023-12-11

Transpara Density 1.0.0

Applicant Screenpoint Medical B.V.

K-Number K232096

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FXX 2023-12-11

Hygenix

Applicant Shenzhen Hygenix Industrial Co., Ltd.

K-Number K232797

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GEI 2023-12-11

INTELLIO SHIFT System

Applicant ArthroCare Corporation

K-Number K232290

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PGY 2023-12-11

24HR513C

Applicant Lg Electronics.Inc

K-Number K232985

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