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

FZP 2019-12-20

Dannik Titanium Ligation Clip

Applicant Dannik

K-Number K192711

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HRY 2019-12-20

NanoOrtho NanoKnee® System

Applicant Nanoortho, LLC

K-Number K190633

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PEA 2019-12-20

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

Applicant Pentax of America, Inc.

K-Number K190805

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OWB 2019-12-20

Ziehm Vision FD

Applicant Ziehm Imaging GmbH

K-Number K193230

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HIH 2019-12-19

Aveta Disposable Hysteroscope

Applicant Meditrina, Inc.

K-Number K192100

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CJW 2019-12-19

Albumin BCP

Applicant SENTINEL CH. SpA

K-Number K193001

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GEI 2019-12-19

Monopolar Cord

Applicant New Deantronics Taiwan , Ltd.

K-Number K193004

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BZQ 2019-12-19

The RHEA Vital Sign Vigilance System

Applicant Shenzhen Fiber Medical Technology Co. , Ltd.

K-Number K190775

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KRA 2019-12-19

Hereaeus Poseidon Microcatheter

Applicant Heraeus Medical Components, LLC

K-Number K191305

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NXC 2019-12-19

Krystal Klear Aligners

Applicant Shatkin F.I.R.S.T., LLC

K-Number K182388

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FMI 2019-12-19

TK Sterile Hypodermic Needle

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K191643

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ODP 2019-12-19

4CIS Marlin PEEK ACIF Cage

Applicant Solco Biomedical Co., Ltd.

K-Number K192044

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