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

FLL 2021-01-25

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

Applicant Uni-Trend Technology (China) Co., Ltd.

K-Number K203747

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MAX 2021-01-25

VERTACONNECT TLIF Cage

Applicant Signus Medizintechnik

K-Number K203327

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NPK 2021-01-23

Cytoplast Titanium-Reinforced PTFE Membranes

Applicant Osteogenics Biomedical, Inc.

K-Number K201187

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MHX 2021-01-23

Patient Monitor

Applicant Edan Instruments, Inc.

K-Number K202336

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DZE 2021-01-22

Simply Iconic Implants

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K201553

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NFO 2021-01-22

NuFace Trinity Plus Device

Applicant Carol Cole Company Dba Nuface

K-Number K201782

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QGT 2021-01-22

Nerivio, FGD000075-4.7

Applicant Theranica Bioelectronics , Ltd.

K-Number K203181

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JAA 2021-01-22

Platinum dRF Imaging System

Applicant Apelem-Dms Group

K-Number K203010

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HSB 2021-01-22

Flex-ThreadTM Distal Fibula Intramedullary Nail System

Applicant Conventus Orthopaedics, LLC

K-Number K202858

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GEX 2021-01-22

MIIN

Applicant Medico USA, Inc.

K-Number K193266

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GEI 2021-01-22

VirtueRF

Applicant ShenB Co., Ltd.

K-Number K202415

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GEI 2021-01-22

ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K201696

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