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

DQY 2020-01-13

Route 92 Medical Sheath System

Applicant Route 92 Medical, Inc.

K-Number K191717

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MAX 2020-01-13

nva, nvp, and nvt

Applicant Nvision Biomedical Technologies, Inc.

K-Number K193645

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EFB 2020-01-13

Midwest Rhino XE and Air Motor M

Applicant Dentsply Sirona

K-Number K192409

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IPF 2020-01-11

TENS and EMS Stimulator, TENS Stimulator

Applicant Astek Technology , Ltd.

K-Number K183074

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GCJ 2020-01-10

IP Converter

Applicant Sony Electronics, Inc.

K-Number K191678

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BTR 2020-01-10

Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff

Applicant Salter Labs, Inc.

K-Number K190878

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DPS 2020-01-10

KardioScreen

Applicant Imedrix Inc. (Formerly Piitech Inc.)

K-Number K191692

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LZA 2020-01-10

Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K192315

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HRS 2020-01-10

MotoBAND CP Implant System

Applicant Crossroads Extemity Systems, LLC

K-Number K193452

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EBZ 2020-01-10

Cybird LED Curing Light

Applicant Dxm Co., Ltd.

K-Number K191221

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PHX 2020-01-10

Univers Revers Modular Glenoid System (Augemented baseplates)

Applicant Arthrex, Inc.

K-Number K193372

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NKB 2020-01-10

CD Horizon Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K193011

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