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

MMX 2020-06-03

Halo Single-Loop Snare Kit

Applicant Argon Medical Devices, Inc.

K-Number K200268

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PKC 2020-06-03

AltiVate Anatomic Canal-Sparing (CS) Shoulder

Applicant Encore Medical L.P.

K-Number K193226

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QIH 2020-06-03

QLAB Advanced Quantification Software

Applicant Philips Health Care

K-Number K200974

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MJN 2020-06-03

pREBOA-PRO Catheter

Applicant Prytime Medical Devices, Inc.

K-Number K200459

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OAP 2020-06-03

Hair Growth System

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K200929

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DQY 2020-06-03

Agilis HisPro Steerable Catheter With Electrodes

Applicant Abbott (St. Jude Medical)

K-Number K200721

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OCL 2020-06-03

Cardioblate Gemini-s Surgical Ablation Device

Applicant Medtronic

K-Number K200514

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HBL 2020-06-02

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

Applicant Pro Med Instruments GmbH

K-Number K193438

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HRN 2020-06-02

MIRA Adapter

Applicant Phakos

K-Number K200911

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MOS 2020-06-02

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil

Applicant Neocoil, LLC

K-Number K201101

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LPL 2020-06-02

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

Applicant Bausch + Lomb, Incorporated

K-Number K200528

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PKL 2020-06-02

gastroduodenal FTRD Set

Applicant Ovesco Endoscopy AG

K-Number K200684

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