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

LJE 2020-01-29

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

Applicant Cook Incorporated

K-Number K191498

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FCG 2020-01-29

Biopsy Needle

Applicant Ushare Medical, Inc.

K-Number K191472

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NHA 2020-01-29

TruAbutment DS

Applicant Truabutment, Inc.

K-Number K183106

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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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