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

ELW 2018-09-13

HySil Impression Materials

Applicant Osstem Implant Co., Ltd.

K-Number K181236

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JGJ 2018-09-12

Magnesium

Applicant Abbott Laboratories

K-Number K181748

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MQV 2018-09-12

PRODENSE Bone Graft Substitute

Applicant Wrightmedicaltechnologyinc

K-Number K181255

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MQV 2018-09-12

BioSphere Flex

Applicant Synergy Biomedical

K-Number K173424

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MAX 2018-09-11

LnK Lumbar Interbody Fusion Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K181380

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MQN 2018-09-11

Stryker Pediatric Mandibular Distractor 2

Applicant Stryker

K-Number K181504

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MWI 2018-09-11

AirStrip RPM InvisionHeart Adapter

Applicant Airstrip Technologies, Inc.

K-Number K182226

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QDA 2018-09-11

ECG App

Applicant Apple, Inc.

K-Number DEN180044

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NHA 2018-09-11

TruBase S

Applicant Truabutment, Inc.

K-Number K171532

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DQD 2018-09-11

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

Applicant Imediplus, Inc.

K-Number K182196

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OHT 2018-09-11

IPL Salon Hair Reduction System

Applicant Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt

K-Number K181568

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QDB 2018-09-11

Irregular Rhythm Notification Feature

Applicant Apple, Inc.

K-Number DEN180042

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