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

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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NHA 2019-12-19

Neodent Implant System- GM Titanium Base for Bridge

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K192229

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FBK 2019-12-19

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K-Number K190829

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OWB 2019-12-19

uMC 560i

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K183144

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NUH 2019-12-19

Everyway OTC TENS/EMS Combination

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K192589

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DYB 2019-12-19

Halo One Thin-Walled Guiding Sheath

Applicant C.R. Bard, Inc.

K-Number K192313

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IYN 2019-12-19

ZS3 and z.one pro Ultrasound Systems

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K192410

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LLZ 2019-12-19

DentiqAir

Applicant 3D Industrial Imaging Co., Ltd.

K-Number K183676

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EHD 2019-12-19

EZER, Portable X-ray System

Applicant Livermoretech, Inc.

K-Number K190935

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MHX 2019-12-19

ZOLL Arrhythmia Management Sysyem

Applicant Zoll Manufacturing Corporation

K-Number K190939

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HKY 2019-12-19

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

Applicant Chongqing Sunkingdom Medical Instrument Co., Ltd.

K-Number K191314

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