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

CCW 2019-08-02

APA Oxy Blade

Applicant Venner Medical (Singapore) Pte, Ltd.

K-Number K191602

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PTD 2019-08-02

PowerFlow Implantable Apheresis IV Port

Applicant C.R. Bard, Inc.

K-Number K191143

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OWI 2019-08-02

JAZZ PF

Applicant Implanet, S.A.

K-Number K191217

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DQX 2019-08-01

MINAMO

Applicant Asahi Intecc Co., Ltd.

K-Number K190176

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NUC 2019-08-01

JO Premium Jelly Original Personal Lubricant

Applicant United Consortium

K-Number K191214

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PKL 2019-08-01

Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip

Applicant Olympus Medical Systems Corp.

K-Number K183590

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DYB 2019-08-01

Steerable Introducer

Applicant Freudenberg Medical, LLC

K-Number K191190

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DRB 2019-08-01

Biotronik Stylets

Applicant Biotronik, Inc.

K-Number K191469

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FEQ 2019-08-01

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

Applicant United States Endoscopy Group, Inc.

K-Number K191559

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HAW 2019-08-01

Leksell Vantage Stereotactic System

Applicant Elekta Instrument AB

K-Number K190887

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MRG 2019-08-01

MAGLUMI 2000 25-OH Vitamin D

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K-Number K191499

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NUH 2019-08-01

Mini TENS Therapy Device

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K182871

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