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

KWQ 2019-03-21

CastleLoc-P Anterior Cervical Plate System

Applicant L&K BIOMED Co., Ltd.

K-Number K190425

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LPH 2019-03-21

MPACT Extension

Applicant Medacta International S.A.

K-Number K183582

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GBM 2019-03-20

SimplCath

Applicant F&S Medical Solutions, LLC

K-Number K182511

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IYO 2019-03-20

ABSOLU

Applicant Quantel Medical

K-Number K183414

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EIH 2019-03-20

Jensen Shade Effect Liquids

Applicant Jensen Industries, Inc.

K-Number K183408

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OMP 2019-03-20

ACTIV.A.C. Therapy Unit

Applicant Kci USA, Inc.

K-Number K183543

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FOZ 2019-03-20

BD Nexiva Closed IV Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K183399

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IYN 2019-03-20

ACUSON S3000, S2000 Diagnostic Ultrasound System

Applicant Siemens Healthineers

K-Number K183575

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JWY 2019-03-19

MTS Ciprofloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K183527

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LPH 2019-03-19

Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

Applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K-Number K182468

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LLZ 2019-03-19

MIM on Linux

Applicant Mim Software, Inc.

K-Number K190379

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JOW 2019-03-19

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

Applicant Devon Medical Products (Jiangsu), Ltd.

K-Number K190423

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