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

LLZ 2018-10-11

OnePacs System

Applicant Onepacs, LLC

K-Number K181460

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LZA 2018-10-10

SBG Black Nitrile Powder Free Medical Examination Glove

Applicant Showa Best Glove, Inc.

K-Number K180468

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QEW 2018-10-10

ClotTriever Thrombectomy System

Applicant Inari Medical

K-Number K182531

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LZA 2018-10-10

SBG Blue Nitrile Powder Free Medical Examination Glove

Applicant Showa Best Glove, Inc.

K-Number K180467

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DXT 2018-10-10

Sterile High-pressure Angiographic Syringes for Single-use

Applicant Shenzhen Baoan Medical Supplies Co., Ltd.

K-Number K182289

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HGX 2018-10-10

Elvie Pump

Applicant Chiaro Technology Limited

K-Number K181863

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HRS 2018-10-10

Geminus Volar Distal Radius Plate System

Applicant Skeletal Dynamics, LLC

K-Number K182492

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GAT 2018-10-10

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture

Applicant Teleflex Medical Incorporated

K-Number K181774

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PSQ 2018-10-10

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)

Applicant Cormatrix Cardiovascular, Inc.

K-Number K181038

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DZE 2018-10-10

BioHorizons Tapered IM Implants

Applicant BioHorizons Implant Systems, Inc.

K-Number K182070

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NKB 2018-10-10

Cellent Spinal Systems

Applicant Jiangsu Trauhui Medical Instrument Co., Ltd.

K-Number K172826

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FLL 2018-10-10

Temperature Probe

Applicant Orantech, Inc.

K-Number K173194

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