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

FLL 2020-06-17

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

Applicant Shenzhen Changkun Technology Co., Ltd.

K-Number K193253

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QJI 2020-06-16

Control-IQ Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K200467

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NKB 2020-06-16

Spinal Fixation System

Applicant Shangdong Kangsheng Medical Devices Co., Ltd.

K-Number K190408

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JWH 2020-06-16

TRUMATCH Personalized Solutions

Applicant DePuy Orthopaedics, Inc.

K-Number K193540

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GEI 2020-06-16

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

Applicant Modern Medical Equipment Manufacturing, Ltd.

K-Number K192542

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JOW 2020-06-16

Koya Ripple

Applicant Koya, Inc.

K-Number K193288

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JWH 2020-06-16

iTotal® Identity Posterior Stabilized Knee Replacement System

Applicant Conformis, Inc.

K-Number K201023

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HGX 2020-06-15

Pump In Style

Applicant Medela, LLC

K-Number K200508

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HQC 2020-06-15

Visalis V500, Visalis S500

Applicant Carl Zeiss Meditec, AG

K-Number K193376

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DYB 2020-06-15

Abiomed 23 Fr Sheath

Applicant Abiomed, Inc.

K-Number K201116

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QFT 2020-06-15

EndeavorRx

Applicant Akili Interactive Labs, Inc.

K-Number DEN200026

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LLZ 2020-06-15

Quantib AI Node

Applicant Quantib B.V.

K-Number K200899

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