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

OCC 2016-07-25

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System

Applicant Iquum, Inc.

K-Number K153544

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NHA 2016-07-25

NobelProcera HT ML FCZ Implant Bridge and Framework

Applicant Nobel Biocare AB

K-Number K160158

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MOL 2016-07-25

Skyn Original Polyisoprene Lubricated Male Condom

Applicant Ansell Healthcare Products, LLC

K-Number K160399

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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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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 Bird’s 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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