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

OWI 2020-08-05

Mariner Cap System

Applicant SeaSpine Orthopedics Corporation

K-Number K201240

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JDB 2020-08-05

LATITUDE EV Total Elbow Arthroplasty

Applicant Tornier, Inc.

K-Number K193247

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LZA 2020-08-05

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega Sdn Bhd

K-Number K201531

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OUR 2020-08-05

NADIA SI Fusion System

Applicant Ilion Medical, Inc.

K-Number K190580

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LZO 2020-08-05

Spartan Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K192883

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HHK 2020-08-05

CrossGlide ETS Plus

Applicant Crossbay Medical

K-Number K201952

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OLO 2020-08-05

CarboClear Navigated Instruments

Applicant CarboFix Orthopedics , Ltd.

K-Number K201251

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IYN 2020-08-05

XBit Series Digital Color Doppler Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K200780

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QDC 2020-08-05

Adaptive Biotechnologies clonoSEQ Assay

Applicant Adaptive Biotechnologies Corporation

K-Number K200009

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DRN 2020-08-05

Enhanced External Counter Pulsation Device Plus Omay-A

Applicant Omay(Guangzhou)Med Technologies Co., Ltd.

K-Number K191955

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HWC 2020-08-04

Vector Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K201850

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KPS 2020-08-04

HYPER DLR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K193210

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