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

MAX 2024-01-22

restor3d TIDAL Lumbar Interbody Fusion System

Applicant Restor3D

K-Number K234087

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MQZ 2024-01-22

NailLift

Applicant Jps Corporation

K-Number K230841

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PIO 2024-01-22

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

Applicant Cair Lgl

K-Number K231299

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MDI 2024-01-20

RESPONSE™ Rib and Pelvic System

Applicant OrthoPediatrics Corp.

K-Number K233105

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QNR 2024-01-19

LifeSPARC System

Applicant Cardiacassist, Inc.

K-Number K233736

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QAD 2024-01-19

IlluminOss Photodynamic Bone Stabilization System

Applicant Illuminoss Medical, Inc.

K-Number K233436

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HRS 2024-01-19

HKT Anatomical Locking Trauma System

Applicant Hankil Tech Medical Co., Ltd.

K-Number K231213

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IRP 2024-01-19

Cold Compression Wrap Pro

Applicant Chengdu Cryo-Push Medical Technology Co.,Ltd

K-Number K230524

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QEW 2024-01-19

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister

Applicant Argon Medical Devices, Inc.

K-Number K232679

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NUH 2024-01-19

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

Applicant Hi-Dow International, Inc.

K-Number K233461

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QJP 2024-01-19

Distal Access Catheter

Applicant Accumedical Beijing , Ltd.

K-Number K231218

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POK 2024-01-19

Rapid ASPECTS (v3)

Applicant Ischemaview, Inc.

K-Number K232156

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