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

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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FYC 2021-05-20

Surgical Isolation Gown

Applicant Yanbian Pacific Textile Co., Ltd.

K-Number K203415

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FCG 2021-05-20

EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

Applicant Cook Ireland, Ltd.

K-Number K210476

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MEH 2021-05-20

Actis DuoFix Hip Prosthesis- Collarless

Applicant Depuy Ireland UC

K-Number K210581

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KCY 2021-05-20

ATS 5000 Automatic Tourniquet Instrument

Applicant Mcewen and Associates Consulting , Ltd.

K-Number K202919

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MWI 2021-05-20

Vitals360 Multi-Vitals Mobile Monitor

Applicant Vocare, Inc.

K-Number K210086

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