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

JGS 2020-02-07

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K183688

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BTG 2020-02-07

Pulmonary Cytology Brush

Applicant Hobbs Medical, Inc.

K-Number K182927

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PAH 2020-02-07

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

Applicant Caldera Medical, Inc.

K-Number K191416

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GYB 2020-02-07

Elefix V Paste for EEG & EMG

Applicant Nihon Kohden Corporation

K-Number K191975

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IYN 2020-02-07

Paragon XHD Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K191347

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POL 2020-02-07

Trevo NXT ProVue Retriever

Applicant Stryker

K-Number K200117

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GXI 2020-02-07

Vesta RF Cannula

Applicant Biomerics

K-Number K190259

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JFL 2020-02-07

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K191298

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NKG 2020-02-07

Yukon OCT Spinal System

Applicant K2m, Inc.

K-Number K193129

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NQL 2020-02-07

NeoBase 2 Non-derivatized MSMS Kit

Applicant Perkinelmer, Inc.

K-Number K193103

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FRO 2020-02-07

Rochal Antimicrobial Wound Gel

Applicant Rochal Industries, LLC

K-Number K192527

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FRC 2020-02-07

3M Attest Super Rapid 5 Steam-Plus Challenge Pack

Applicant 3M Company

K-Number K193154

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