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

LZO 2023-01-05

U-Motion II Acetabular System-Extension line

Applicant United Orthopedic Corporation

K-Number K221149

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JWH 2023-01-05

REMEDY Stemmed Knee Spacer

Applicant Osteoremedies, LLC

K-Number K223650

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POD 2023-01-05

Ax-Surgi Surgical Hemostat

Applicant Advamedica, Inc.

K-Number K213198

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HRS 2023-01-05

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K221181

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ODP 2023-01-05

Cervical Spine Truss System (CSTS) Interbody Fusion Device

Applicant 4Web Medical, Inc.

K-Number K221266

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MAX 2023-01-05

CONDUIT LLIF Straight Inserters

Applicant Enztec Limited

K-Number K223671

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FXX 2023-01-04

Surgical Face Mask

Applicant Hubei Woozon Healthcare Co., Ltd.

K-Number K222483

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GEX 2023-01-04

DEKA HELIX

Applicant El.En Electronic Engineering Spa

K-Number K222221

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DXC 2023-01-04

Radial Artery Compression Tourniquets

Applicant Beijing Demax Medical Technology Co.,Ltd

K-Number K222182

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HGX 2023-01-04

Wearable Breast Pump (Model S1DW)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K222045

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MZO 2023-01-04

Elecsys Anti-HCV II (08837031190)

Applicant Roche Diagnostics

K-Number K221693

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GEX 2023-01-04

SmoothCool HR System

Applicant Jeisys Medical, Inc.

K-Number K223685

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