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

MBI 2020-01-29

MectaTap TI Suture Anchor

Applicant Medacta International S.A.

K-Number K191677

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JOW 2020-01-29

Ezvena IPC, Ezvena SQS

Applicant Eezcare Medical Corp

K-Number K191937

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PHX 2020-01-29

Anatomical Shoulder System

Applicant Zimmer GmbH

K-Number K193099

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NXC 2020-01-29

UniSmile Clear Aligner System

Applicant Vitang Technology, LLC

K-Number K191837

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OAP 2020-01-29

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

Applicant Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

K-Number K192585

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LSR 2020-01-29

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

Applicant DiaSorin, Inc.

K-Number K193051

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KPR 2020-01-28

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

Applicant Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K-Number K193637

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LQZ 2020-01-28

The NightBlocks Appliance

Applicant Advanced Facialdontics, LLC

K-Number K192581

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MQH 2020-01-28

V-DENUPET

Applicant Vitromed GmbH

K-Number K192146

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IYN 2020-01-28

Terason uSmart3200T Ultrasound System

Applicant Teratech Corporation

K-Number K193510

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OCU 2020-01-27

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile

Applicant STERIS Corporation

K-Number K191715

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NKB 2020-01-27

M.U.S.T. Pedicle Screw System

Applicant Medacta International S.A.

K-Number K193365

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