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

LYZ 2016-07-25

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating

Applicant Cardinal Health, Inc.

K-Number K160411

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NHI 2016-07-23

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

Applicant Spr Therapeutics, LLC

K-Number K161154

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OYX 2016-07-22

Quantidex qPCR BCR-ABL IS Kit

Applicant Asuragen, Inc.

K-Number DEN160003

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HBC 2016-07-22

ELAN 4 Motor System

Applicant Aesculap, Inc.

K-Number K152960

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PNI 2016-07-22

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

Applicant Kronus, Inc.

K-Number K161951

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PGM 2016-07-22

K2M Growing Spine System

Applicant K2m, Inc.

K-Number K161028

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JIL 2016-07-22

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

Applicant Teco Diagnostics, Inc.

K-Number K160372

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DTK 2016-07-22

Gianturco-Roehm Birds Nest Vena Cava Filter

Applicant Cook Incorporated

K-Number K161218

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PHL 2016-07-22

ReWalk(TM)

Applicant Rewalk Robotics, Inc.

K-Number K160987

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MQL 2016-07-22

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Applicant Origio A/S

K-Number K153267

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DZE 2016-07-22

ST Internal Fixture System

Applicant T-Plus Implant Tech. Co., Ltd.

K-Number K152787

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FRG 2016-07-22

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K-Number K160908

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