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

IRP 2021-03-05

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)

Applicant Maxstar Industrial Co., Ltd.

K-Number K191441

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FXX 2021-03-05

Surgical Mask

Applicant Bdc Dental Corporation , Ltd.

K-Number K203425

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QNU 2021-03-05

ClearUP Sinus Relief

Applicant Tivic Health Systems, Inc.

K-Number DEN200006

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IYN 2021-03-05

Vivid E80/ Vivid E90/ Vivid E95

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K202658

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GXY 2021-03-05

NeuroCap (Model DEC22)

Applicant Memory MD, Inc.

K-Number K202913

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LZA 2021-03-05

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

Applicant Shen Wei USA, Inc.

K-Number K202078

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POK 2021-03-05

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

Applicant Optellum, Ltd.

K-Number K202300

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FXX 2021-03-04

Disposable medical mask

Applicant U-Play Products Corporation

K-Number K202137

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MHC 2021-03-04

BD Intraosseous Infusion System

Applicant Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]

K-Number K203193

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FXX 2021-03-04

Surgical Face Mask

Applicant Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.

K-Number K210225

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LNH 2021-03-04

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K203323

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BZQ 2021-03-04

Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation

Applicant Hill-Rom, Inc.

K-Number K202018

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