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

FRO 2019-09-13

Roosin Xeroform Petrolatum Dressing

Applicant Roosin Medical Co., Ltd.

K-Number K181478

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HWC 2019-09-13

TDM Screw Systems

Applicant Tdm Co., Ltd.

K-Number K190830

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LLZ 2019-09-13

SIS Software Version 3.6.0

Applicant Surgical Information Sciences, Inc.

K-Number K192304

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KPR 2019-09-12

uDR 592h, uDR 596i

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K192293

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FMF 2019-09-12

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

Applicant Shanghai Kohope Medical Devices Co., Ltd.

K-Number K190002

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PNN 2019-09-12

OrthoAnalysis Software

Applicant Inteware Co., Ltd.

K-Number K183695

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OWB 2019-09-12

ARTIS icono

Applicant Siemens Medical Solutions USA, Inc.

K-Number K190768

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KPT 2019-09-12

CRC PC Smart Chamber K1

Applicant Capintec, Inc.

K-Number K192199

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FRO 2019-09-12

Saline Wound Wash, SteriCleanse(TM)

Applicant Ascent Consumer Products, Inc.

K-Number K183662

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PML 2019-09-12

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K191148

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IPL 2019-09-12

UPnRIDE

Applicant Upnride Robotics , Ltd.

K-Number K182257

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OHS 2019-09-12

faceLITE

Applicant Ismart Marketing Svcs, Ltd.

K-Number K191629

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