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

DPS 2016-05-06

Diagnostic Station DS20

Applicant Schiller AG

K-Number K152043

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MAX 2016-05-06

NeoFuse HA Enhanced PLIF/TLIF

Applicant Ht Medical, LLC

K-Number K153615

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BZQ 2016-05-06

EarlySense Insight Sytem

Applicant Earlysense, Ltd.

K-Number K152911

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DZE 2016-05-06

TOUAREG CloseFit UNP 2.75mmD

Applicant Adin Dental Implants Systems , Ltd.

K-Number K153111

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ETN 2016-05-06

FREMAP ELECTRODE

Applicant Ad-Tech Medical Instrument Corporation

K-Number K152769

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KNT 2016-05-06

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

Applicant Consure Medical Pvt , Ltd.

K-Number K153506

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HSN 2016-05-06

INVISION Total Ankle Revision System

Applicant Wrightmedicaltechnologyinc

K-Number K153008

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MQL 2016-05-06

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K152717

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NLM 2016-05-06

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K160740

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KIF 2016-05-06

Pulp Canal Sealer, Pulp Canal Sealer EWT

Applicant Sybron Dental Specialties

K-Number K152956

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NUH 2016-05-05

Electronic Pulse Stimulator

Applicant Jkh Health Co., Ltd.

K-Number K153520

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IYO 2016-05-05

Enovare Ultrasound System

Applicant Oreon Technologies, Inc.

K-Number K153620

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