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

DQK 2021-05-21

Zio ECG Utilization Software (ZEUS) System

Applicant iRhythm Technologies, Inc.

K-Number K202527

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LFL 2021-05-21

Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

Applicant Ethicon Endo-Surgery, LLC

K-Number K211273

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DSH 2021-05-21

Zio Monitor

Applicant iRhythm Technologies, Inc.

K-Number K202359

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EBW 2021-05-21

Impla-NX (Model: ISE-270M)

Applicant Micro-Nx Co., Ltd.

K-Number K201192

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LLZ 2021-05-20

Xoran Workstation, Model 10050

Applicant Xoran Technologies, LLC

K-Number K210257

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MBF 2021-05-20

Ignite Anatomic Shoulder System

Applicant Ignite Orthopedics, LLC

K-Number K202716

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FLL 2021-05-20

YUWELL infrared ear thermometer: YHT101, YHT200

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K-Number K203583

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IYE 2021-05-20

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner

Applicant Medtec, Inc. Dba Civco Medical Solutions and Civco

K-Number K211001

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GWL 2021-05-20

Quick-20m

Applicant Cgx, LLC

K-Number K203331

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FXX 2021-05-20

Procedure Mask, Surgical Mask

Applicant Kenpax International Limited

K-Number K202899

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NRY 2021-05-20

Penumbra System (Reperfusion Catheter RED 62)

Applicant Penumbra, Inc.

K-Number K203440

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QPD 2021-05-20

VR101 Lubricating Intravaginal Ring

Applicant J3 Bioscience, Inc.

K-Number K203377

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