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

LIT 2020-05-20

Infinity Angioplasty Balloon Catheter

Applicant Infinity Angioplasty Balloon Company, LLC

K-Number K192399

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ESW 2020-05-20

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

Applicant M.I.Tech Co., Ltd.

K-Number K200860

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FPA 2020-05-20

LifeFlow Blood System

Applicant 410 Medical, Inc.

K-Number K191362

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KWQ 2020-05-20

NuVasive® ACP System

Applicant Nu Vasive, Incorporated

K-Number K201078

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DHR 2020-05-20

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

Applicant Kamiya Biomedical Company

K-Number K192727

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OVD 2020-05-20

Axis Spine Technologies ALIF

Applicant Axis Spine Technologies, Ltd.

K-Number K200352

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NKB 2020-05-19

Reform Pedicle Screw System

Applicant Precision Spine

K-Number K200303

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PGY 2020-05-19

5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K200864

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IZL 2020-05-19

TOPAZ Mobile DR System

Applicant DRGEM Corporation

K-Number K201124

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IYO 2020-05-19

CUBEScan BioCon-900S

Applicant Mcube Technology Co., Ltd.

K-Number K200749

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ITI 2020-05-19

SMOOV O10

Applicant Alber GmbH

K-Number K192016

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OOE 2020-05-18

Catalys Precision Laser System

Applicant Amo Manufacturng USA, LLC

K-Number K200056

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