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

MAX 2020-04-02

EVOS Lumbar Interbody System

Applicant Cutting Edge Spine, LLC

K-Number K200552

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KOI 2020-04-02

TwitchView System

Applicant Blink Device Company

K-Number K192958

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IYN 2020-04-02

Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System

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

K-Number K200251

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IOR 2020-04-01

Manual Wheelchair

Applicant Jerry Medical Instrument (Shanghai) Co., Ltd.

K-Number K192658

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JAK 2020-04-01

SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200524

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PSW 2020-04-01

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

Applicant Cs Medical, LLC

K-Number K192228

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IYN 2020-04-01

LOGIQ E10s

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K200119

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GEI 2020-04-01

Venus VivaTM

Applicant Venus Concept USA, Inc.

K-Number K191065

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KGO 2020-04-01

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use

Applicant Medline Industries, Inc.

K-Number K192988

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DZE 2020-04-01

DSI Dental Implant System

Applicant Dsi Dental Solutions, Ltd.

K-Number K200188

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MQB 2020-04-01

Focus 43C detector, TRIMAX 43C detector

Applicant Iray Technology Taicang , Ltd.

K-Number K200622

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ONN 2020-04-01

VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left

Applicant Orthosensor, Inc.

K-Number K193580

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