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

IYO 2020-07-16

FibroScan® 630

Applicant Echosens

K-Number K200655

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FLL 2020-07-16

Infrared Thermometer Model Number RN-50A,RN-50B

Applicant Ningbo Ranor Medical Science & Technology Co., Ltd.

K-Number K200578

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HWC 2020-07-16

REDUCT® Headless Compression Screw System

Applicant Skeletal Dynamics, Inc.

K-Number K201662

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IYN 2020-07-16

Vivid S60N, Vivid S70N

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K200497

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QKQ 2020-07-15

FullFocus

Applicant Paige.Ai, Inc.

K-Number K201005

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DRG 2020-07-15

LifeSignals ECG Remote Monitoring Patch Platform

Applicant Lifesignals, Inc.

K-Number K200690

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MAX 2020-07-15

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System

Applicant Innovasis, Inc.

K-Number K201614

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LPL 2020-07-15

Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens

Applicant Visco Vision, Inc.

K-Number K201080

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FLL 2020-07-15

iHealth Infrared No-Touch Forehead Thermometer

Applicant Andon Health Co, Ltd.

K-Number K200531

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GEI 2020-07-15

Encision AEM enTouch 2X Scissor

Applicant Encision, Inc.

K-Number K201018

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MAX 2020-07-15

EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage

Applicant Eit Emerging Implant Technologies GmbH

K-Number K201605

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PHX 2020-07-15

Humelock TiN Coated Glenosphere

Applicant Fx Shoulder USA, Inc.

K-Number K191146

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