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

FRO 2019-10-11

Protego Antimicrobial Wound Dressing

Applicant Global Health Solutions (Dba Turn Therapeutics)

K-Number K183681

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IZI 2019-10-10

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

Applicant Olympus Medical Systems Corp.

K-Number K190772

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JEC 2019-10-10

DigiFix Sterile Kit

Applicant Virak Orthopedics, LLC

K-Number K192465

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LXJ 2019-10-10

VERA

Applicant Reflexion Health, Inc.

K-Number K192474

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NHA 2019-10-10

Legacy SMARTBase Abutments

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K191458

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MUU 2019-10-10

KTA Adipose Treatment Kit

Applicant Stemics S.A.S

K-Number K190386

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PIR 2019-10-10

Mercy babyTAPE

Applicant Children'S Mercy Hospital

K-Number K191174

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GEX 2019-10-10

Waterlase Laser System Family

Applicant Biolase, Inc.

K-Number K190319

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NUH 2019-10-10

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

Applicant Shenzhen Osto Technology Co., Ltd.

K-Number K182136

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PJN 2019-10-10

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

Applicant Ossdsign AB

K-Number K190523

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DQA 2019-10-10

Belun Ring

Applicant Belun Technology Company Limited

K-Number K191417

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FLL 2019-10-10

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

Applicant Fiab Spa

K-Number K192210

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