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

NQE 2018-03-14

Specular Microscope CEM-530

Applicant Nidek Co., Ltd.

K-Number K173980

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LZO 2018-03-14

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared

Applicant Medacta International S.A.

K-Number K173794

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FLL 2018-03-14

Infrared Thermometer

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K172795

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HEW 2018-03-14

Advincula Delineator Uterine Manipulator

Applicant CooperSurgical, Inc.

K-Number K180429

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NXC 2018-03-13

Custom Clear Aligner System

Applicant Derby Dental Laboratory

K-Number K173785

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PJJ 2018-03-13

STERIZONE VP4 Sterilizer

Applicant Tso3, Inc.

K-Number K173694

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FTM 2018-03-13

Biodesign Diaphragmatic Hernia Graft

Applicant Cook Biotech Incorporated

K-Number K171817

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NEZ 2018-03-13

Olympus Small Intestinal Capsule Endoscope System

Applicant Olympus Medical Systems Corp.

K-Number K173459

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IYE 2018-03-13

ThinkQA

Applicant Dosisoft

K-Number K180106

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IYN 2018-03-13

Voluson S8/ Voluson S10/ Voluson S10 Expert

Applicant GE Healthcare

K-Number K180374

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MOB 2018-03-13

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

Applicant Phadia AB

K-Number K173792

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OQI 2018-03-12

Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners

Applicant Exactech, Inc.

K-Number K173583

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