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

LDJ 2019-10-11

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

Applicant Shenzhen Bioeasy Biotechnology Co., Ltd.

K-Number K192515

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GEI 2019-10-11

AEON Laparoscopic Instruments

Applicant Lexington Medical, Inc.

K-Number K192235

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MQP 2019-10-11

CarboClear VBR System

Applicant CarboFix Orthopedics , Ltd.

K-Number K192214

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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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