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

DXN 2019-05-16

Tel-O-Graph

Applicant I.E.M. Industrielle Entwicklung and Medizintechnik

K-Number K173895

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PQA 2019-05-16

Aptima CV/TV Assay

Applicant Hologic, Inc.

K-Number K190472

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JWH 2019-05-16

EVOLUTION NitrX Medial-Pivot Knee

Applicant Mircoport Orthopedics, Inc.

K-Number K182251

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MXK 2019-05-16

ARGOS

Applicant Santec Corporation

K-Number K191051

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KNS 2019-05-15

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

Applicant Olympus Medical Systems Corp.

K-Number K182408

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DQY 2019-05-15

SOFIA EX Intracranial Support Catheter

Applicant MicroVention, Inc.

K-Number K182602

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MDB 2019-05-15

BACT/ALERT MP Reagent System

Applicant bioMerieux, Inc.

K-Number K190405

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LCX 2019-05-15

VeriClear Digital Early Result Pregnancy Test

Applicant True Diagnostics, Inc.

K-Number K182328

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FED 2019-05-15

Flexible Overtube

Applicant Sumitomo Bakelite Co., Ltd.

K-Number K182520

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IRP 2019-05-15

Recovery Pump, 737R (RPX)

Applicant Mego Afek AC , Ltd.

K-Number K190493

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PPU 2019-05-15

APAS Independence with Urine Analysis Module

Applicant Clever Culture Systems AG

K-Number K183648

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DSI 2019-05-15

Liba3 System

Applicant National Cardiac, Inc.

K-Number K182532

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