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

OHV 2019-09-09

Sofacia System

Applicant Sofwave Medical, Ltd.

K-Number K191421

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LDS 2019-09-09

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector

Applicant Cenorin, LLC

K-Number K183444

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GCJ 2019-09-09

Connected OR Hub with Device and Voice Control

Applicant Stryker

K-Number K192172

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GEX 2019-09-09

Precise SHP Diode Laser

Applicant CAO Group, Inc.

K-Number K181601

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ODP 2019-09-09

Ti3Z Cervical Interbody System

Applicant Zavation Medical Products, LLC

K-Number K191354

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MOS 2019-09-09

Encompass 15 Channel Head Coil, 3T

Applicant Qfix

K-Number K190668

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NUH 2019-09-07

Focus TENS Therapy, Model PM710-M/-L

Applicant Omron Healthcare, Inc.

K-Number K183215

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MEG 2019-09-06

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use

Applicant Jiangsu Micsafe Medical Technology Co., Ltd.

K-Number K183665

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PJB 2019-09-06

Steerable catheter control system

Applicant Stereotaxis, Inc.

K-Number K183027

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HSB 2019-09-06

TTC Phantom Intramedullary Nail System

Applicant Paragon 28, Inc.

K-Number K191782

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QIA 2019-09-06

Klinly Ultrasonic Tongue Cleaner

Applicant Kea Products, Ltd.

K-Number K181986

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OCX 2019-09-06

Vacutore Air/Water Bottle Tubing

Applicant Smartdata Suzhou Co., Ltd.

K-Number K191366

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