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

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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MUJ 2020-08-13

Syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K201444

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BSK 2020-08-13

Cuffix

Applicant Biovo Technologies , Ltd.

K-Number K192611

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OYJ 2020-08-13

AncestryDNA Saliva Collection Kit

Applicant Ancestry Genomics, Inc.

K-Number K192947

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QAD 2020-08-13

IlluminOss Photodynamic Bone Stabilization System

Applicant Illuminoss Medical, Inc.

K-Number K201961

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LLZ 2020-08-13

Braid

Applicant Braid.Health

K-Number K200822

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MBB 2020-08-13

SpaceFlex Knee - 80mm Size

Applicant G21, S.R.L.

K-Number K201960

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GEI 2020-08-12

Aurora Evacuator +Coag

Applicant Rebound Therapeutics

K-Number K201637

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LXV 2020-08-12

Orion

Applicant Interacoustics A/S

K-Number K200529

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