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

DXE 2021-09-07

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

Applicant Applied Medical Resources Corporation

K-Number K202049

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OVD 2021-09-07

OneLIF Intervertebral Body Replacement System

Applicant Novapproach Spine

K-Number K211769

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GEI 2021-09-07

CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)

Applicant Bolder Surgical, LLC

K-Number K211579

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FMF 2021-09-07

PreferX Delivery System

Applicant Md3, LLC

K-Number K210997

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FJK 2021-09-06

SANSIN Tubing Sets for Hemodialysis

Applicant Jiangxi Sanxin Medtec Co., Ltd.

K-Number K202796

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JOJ 2021-09-05

3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228

Applicant 3M Company

K-Number K212081

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NUH 2021-09-05

Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

Applicant Shenzhen Osto Technology Company Limited

K-Number K211736

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LFD 2021-09-03

Dentilube Spray

Applicant Oxy2plus, LLC

K-Number K202689

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FAJ 2021-09-03

KARL STORZ Flexible HD Cysto-Urethroscope System

Applicant Karl Storz Endoscopy America, Inc.

K-Number K212476

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FXX 2021-09-03

Altor Safety 4-Ply Surgical Mask (Model:62232)

Applicant Altor Safety, LLC

K-Number K211762

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JOW 2021-09-03

WoundExpress

Applicant Huntleigh Healthcare , Ltd.

K-Number K211200

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CAC 2021-09-03

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

Applicant Atrium Medical Corporation

K-Number K201305

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