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

FXX 2016-06-15

Disposable Surgical Face Mask

Applicant Xiantao Rayxin Medical Products Co., Ltd.

K-Number K153496

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KGE 2016-06-14

Disposable Hot Biopsy Forceps

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K160625

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JWH 2016-06-14

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

Applicant Conformis, Inc.

K-Number K161366

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IYE 2016-06-14

Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution

Applicant Qfix

K-Number K160627

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NUC 2016-06-14

ally Warming Liquid Personal Lubricant

Applicant Private Label Production, LLC

K-Number K160717

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LJS 2016-06-14

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter

Applicant C.R. Bard, Inc.

K-Number K151985

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IMJ 2016-06-14

Megapulse III Shortwave Diathermy

Applicant Accelerated Care Plus

K-Number K153456

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LBI 2016-06-14

Airborne Phototherapy Light

Applicant International Biomedical

K-Number K160238

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DXN 2016-06-14

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K161156

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HIH 2016-06-14

Symphion Endoscope and Symphion Cervical Sheath

Applicant Boston Scientific

K-Number K160751

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DQY 2016-06-14

ASAHI Corsair Armet

Applicant Asahi Intecc Co., Ltd.

K-Number K161362

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DXQ 2016-06-13

Medline Singe Patient Use Blood Pressure Cuff

Applicant Medline Industries, Inc.

K-Number K161035

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