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

DRG 2020-01-07

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

Applicant VivaLNK, Inc.

K-Number K191870

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GEI 2020-01-07

CRF Radiofrequency Ablation System

Applicant Cambridge Interventional, LLC

K-Number K192715

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LZA 2020-01-07

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color

Applicant Ever Growth (Vietnam) Co. , Ltd.

K-Number K190942

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FMF 2020-01-06

TK Sterile Piston Syringe without Needle

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K191642

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LNH 2020-01-06

MRIaudio PREM System with MRIview

Applicant Mriaudio, Inc.

K-Number K193102

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MAX 2020-01-06

EVOL ha - D Lateral Interbody Fusion System

Applicant Cutting Edge Spine, LLC

K-Number K192497

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IYN 2020-01-06

RS85 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K192903

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NHA 2020-01-06

Multi-unit Abutments

Applicant Medentika GmbH

K-Number K191123

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LZO 2020-01-06

Quadra-P

Applicant Medacta International S.A.

K-Number K192827

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EFB 2020-01-06

SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece

Applicant Dentalez, Inc.

K-Number K192412

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LLZ 2020-01-06

ViewPoint 6

Applicant Ge Medical Systems Ultrasound And

K-Number K192917

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DYB 2020-01-06

R2P Destination Slender Guiding Sheath

Applicant Terumo Medical Corporation

K-Number K193125

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