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

IOR 2017-11-16

Merits Model R106/R136 Rehab Wheelchair

Applicant Merits Healthcare Industries (Suzhou) Co., Ltd.

K-Number K170517

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OQG 2017-11-16

Renovis Surgical Hip Replacement System

Applicant Renovis Surgical Technologies

K-Number K171543

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OCW 2017-11-15

OverStitch SX Endoscopic Suturing System (ESS)

Applicant Apollo Endosurgery, Inc.

K-Number K171886

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LYZ 2017-11-15

Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color

Applicant Anhui Kindguard Medical Supplies Technology Co., Ltd.

K-Number K173016

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JDQ 2017-11-15

Arthrex FiberTape Cerclage

Applicant Arthrex, Inc.

K-Number K170206

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EBF 2017-11-15

Registrado Scan

Applicant Voco GmbH

K-Number K171815

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LLZ 2017-11-15

jFit Surgical Planner

Applicant Jointvue, LLC

K-Number K173329

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IYN 2017-11-15

U50 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K173003

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MHX 2017-11-15

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K171901

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MQG 2017-11-15

Geri Embryo Incubator and Geri Dish

Applicant Genea Biomedx Pty, Ltd.

K-Number K171736

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LZA 2017-11-15

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs

Applicant Zhonghong Pulin Medical Products Co., Ltd.

K-Number K171873

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PZR 2017-11-15

NSS-2 System

Applicant Innovative Health Solutions (Ihs), Inc.

K-Number DEN170018

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