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

MWI 2020-08-10

Masimo Rad-97 Pulse CO-Oximeter and Accessories

Applicant Masimo Corporation

K-Number K193626

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ODP 2020-08-10

GS Medical AnyPlus PEEK Cage System

Applicant GS Medical Co., Ltd.

K-Number K200592

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QCI 2020-08-09

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

Applicant Tonica Elektronik A/S

K-Number K193006

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DXT 2020-08-07

Sterile High-pressure Angiographic Syringes for Single-use

Applicant Shenzhen Boon Medical Supply Co., Ltd.

K-Number K192657

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NKB 2020-08-07

CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K201926

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FOZ 2020-08-07

MedSource CathMED IV Catheter

Applicant Medsource Labs

K-Number K193278

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DJG 2020-08-07

LZI Fentanyl II Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K201938

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NXC 2020-08-07

MVP Aligner System

Applicant Mvp Aligners, LLC

K-Number K193130

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KNW 2020-08-07

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices

Applicant Transmed7, LLC

K-Number K201244

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QAS 2020-08-07

Accipiolx

Applicant Maxq AL , Ltd.

K-Number K201310

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MBI 2020-08-07

6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor

Applicant Medos International SARL

K-Number K201883

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MQB 2020-08-07

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)

Applicant Careray Digital Medical System Co., Ltd.

K-Number K201932

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