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

MHX 2016-08-04

Surveyor S4 Mobile Monitor

Applicant Mortara Instrument, Inc.

K-Number K160685

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FRG 2016-08-04

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

Applicant Safe Secure Packaging Co., Ltd.

K-Number K153540

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ONF 2016-08-04

IPL Therapy Machine

Applicant Beijing Adss Development Co., Ltd.

K-Number K161286

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OMP 2016-08-04

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply

Applicant Smith & Nephew Medical, Ltd.

K-Number K153209

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LZA 2016-08-03

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

Applicant Kossan International Sdn Bhd

K-Number K151750

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KRD 2016-08-03

Hilal Embolization MicroCoils

Applicant Cook Incorporated

K-Number K160219

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NPM 2016-08-03

A-Oss

Applicant Hiossen, Inc.

K-Number K151542

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MBI 2016-08-03

AFX Femoral Implant With Inserter

Applicant Cayenne Medical, Inc.

K-Number K161033

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FRO 2016-08-03

DURAFIBER Ag

Applicant Smith & Nephew Medical Limited

K-Number K161289

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LLZ 2016-08-03

JointPoint

Applicant Jointpoint, Inc.

K-Number K160284

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KNW 2016-08-03

CASSI II Rotational Core Biopsy System

Applicant Scion Medical Technologies, LLC

K-Number K161234

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BWF 2016-08-03

iPEP System and vPEP

Applicant D R Burton Healthcare, LLC

K-Number K160636

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