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

EBZ 2020-08-14

LOOP LED Curing Light System

Applicant Garrison Dental Solutions, LLC

K-Number K200775

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QJP 2020-08-14

Route 92 Medical 088 Access System

Applicant Route 92 Medical

K-Number K201518

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GZF 2020-08-14

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit

Applicant Micron Medical Corporation

K-Number K200848

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IYE 2020-08-14

The AIO Solution 3.0

Applicant Orfit Industries NV

K-Number K202068

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LLZ 2020-08-13

Limbus Contour

Applicant Limbus Ai, Inc.

K-Number K201232

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JDI 2020-08-13

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup

Applicant Howmedica Osteonics Corp.

K-Number K193429

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PTA 2020-08-13

AncestryDNA Factor V Leiden Genetic Health Risk Test

Applicant Ancestry Genomics, Inc.

K-Number K192944

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NHA 2020-08-13

Straumann® Retentive System Novaloc TiN Abutments

Applicant Institut Straumann AG

K-Number K193046

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PHX 2020-08-13

Univers Revers Modular Glenoid System, Half Augment Baseplate

Applicant Arthrex, Inc.

K-Number K200895

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GZJ 2020-08-13

StimaWELL 120MTRS

Applicant Pierenkemper GmbH

K-Number K181645

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LCX 2020-08-13

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K200133

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DTZ 2020-08-13

Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator

Applicant Sorin Group Italia S.R.L.

K-Number K201916

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