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

MQV 2018-10-24

Osteocera Resorbable Bone Substitute

Applicant Wiltrom Corporation Limited

K-Number K180758

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KPR 2018-10-24

GC70

Applicant Samsung Electronics Co., Ltd.

K-Number K182647

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DQK 2018-10-24

KODEX EPD System

Applicant Philips Medical Systems Nederland B.V.

K-Number K180940

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JWH 2018-10-24

World Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K181530

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OWB 2018-10-24

Cios Alpha

Applicant Siemens Medical Systems USA, Inc.

K-Number K181560

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NKB 2018-10-23

FUSE Pedicle Screw System

Applicant Black Box Medical

K-Number K182283

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FMF 2018-10-23

BD Single Use, Hypodermic Syringe

Applicant Becton, Dickinson and Company

K-Number K172670

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MQL 2018-10-23

Cumulus Remover

Applicant Kitazato Corporation

K-Number K182002

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DQA 2018-10-23

Masimo Rad-97 and Accessories

Applicant Masimo Corporation

K-Number K180046

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MBF 2018-10-23

Humeral Short Stem System

Applicant Shoulder Innovations, Inc.

K-Number K173824

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KNT 2018-10-23

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port

Applicant Covidien

K-Number K180622

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CJY 2018-10-23

Randox Calcium (Ca)

Applicant Randox Laboratories, Ltd.

K-Number K182042

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