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

JWH 2016-09-07

GENflex2 Total Knee System

Applicant Stelkast, Inc.

K-Number K162222

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HAE 2016-09-07

Symmetry Sharp Kerrison Rongeur

Applicant Symmetry Surgical, Inc.

K-Number K161744

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FZP 2016-09-07

Weck Auto Endo10 Automatic Endoscopic Clip Applier

Applicant Teleflex Medical

K-Number K161758

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FQH 2016-09-07

Next Science Irrigation Solution

Applicant Next Science, LLC

K-Number K161165

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CGS 2016-09-07

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K160724

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IYN 2016-09-06

ACUSON SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions Inc. Ultrasound Group

K-Number K162221

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JWH 2016-09-06

Active-X Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K160159

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LJS 2016-09-06

CG+ Arrow JACC

Applicant Arrow International, Inc. (Subsidiary of Teleflex

K-Number K161765

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PNP 2016-09-06

3Shape Abutment Designer Software

Applicant 3Shape A/S

K-Number K151455

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OUY 2016-09-06

BD MAX CT/GC/TV, BD MAX INSTRUMENT

Applicant Becton, Dickinson and Company

K-Number K151589

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MQB 2016-09-06

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)

Applicant Varian Medical Systems, X-Ray Products-Infimed

K-Number K161459

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FXX 2016-09-06

Surgical Face Masks (Ear loops and Tie-on)

Applicant San-M Package Co., Ltd.

K-Number K160269

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