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

QAI 2022-03-07

SkinPen Precision System

Applicant Crown Aesthetics

K-Number K220506

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GEI 2022-03-07

BTL-785W

Applicant BTL Industries, Inc.

K-Number K211639

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FXX 2022-03-04

Surgical Mask

Applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K-Number K213358

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LZA 2022-03-04

Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K210330

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HRS 2022-03-04

PolyLock Plating System

Applicant Fusion Orthopedics

K-Number K211843

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LZA 2022-03-04

Medcare Powder-Free Blue Nitrile Patient Examination Gloves

Applicant Dongguan Grinvald Technology Co., Ltd.

K-Number K211808

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EBI 2022-03-04

Flexible Block

Applicant Shandong Huge Dental Material Corporation

K-Number K213994

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KWS 2022-03-04

Exactech® Equinoxe® Laser Cage Glenoid

Applicant Exactech, Inc.

K-Number K212356

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MYN 2022-03-04

Second Opinion

Applicant Pearl, Inc.

K-Number K210365

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LYC 2022-03-04

InRoad® Dental Synthetic Bone Graft

Applicant Osteogene Tech Corp

K-Number K202675

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IYN 2022-03-04

TE Air Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K220051

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KNN 2022-03-04

KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat

Applicant Kinetic Innovative Seating System, LLC

K-Number K211919

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