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

HGX 2016-08-29

Philips Avent Comfort Single/Twin Electric Breast Pump

Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven

K-Number K161532

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FFK 2016-08-29

UreTron PF Series Probe

Applicant Med-Sonics Corp.

K-Number K162119

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BTM 2016-08-29

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

Applicant Ambu A/S

K-Number K152931

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GXI 2016-08-26

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

Applicant Lccs Products Limited

K-Number K152642

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BZG 2016-08-26

Vitalograph Model 6300 micro

Applicant Vitalograph (Ireland) , Ltd.

K-Number K160253

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NHA 2016-08-26

ATLANTIS Abutment for CONELOG implant

Applicant Dentsply Sirona

K-Number K161030

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HIS 2016-08-26

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant

Applicant Church & Dwight Co., Inc.

K-Number K161545

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FXX 2016-08-26

Skypro, SP01 Mask

Applicant Skypro Medical Supplies Company

K-Number K152197

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GEX 2016-08-26

ORION

Applicant Yerim Engineering Co., Ltd.

K-Number K161503

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IMG 2016-08-26

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

Applicant Accelerated Care Plus (Acp)

K-Number K153559

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IYN 2016-08-26

RS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K162094

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NHA 2016-08-26

GPS Angled Abutment

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K153509

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