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

KWS 2019-07-08

Materialise Glenoid Positioning System

Applicant Materialise NV

K-Number K190286

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NEY 2019-07-08

Microwave Ablation System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K183153

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DZE 2019-07-08

PRAMA White Implant Systems

Applicant Sweden & Martina S.P.A.

K-Number K180365

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NUC 2019-07-08

GLISSANT Intimate Lubricant

Applicant Vjuvenate, LLC

K-Number K183050

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DZE 2019-07-08

Surgikor Dental Implant System

Applicant Surgikor, LLC

K-Number K182615

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LJT 2019-07-08

Bard Power-Injectable Implantable Ports (PowerPorts®)

Applicant C.R. Bard, Inc.

K-Number K181446

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MAX 2019-07-05

Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K-Number K190498

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MAX 2019-07-05

Harrier-SA Lumbar Interbody System

Applicant Choice Spine, LLC

K-Number K191367

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NGX 2019-07-05

Revitive Medic Plus, Revitive Advanced 2

Applicant Actegy , Ltd.

K-Number K190924

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MXD 2019-07-05

BIOMONITOR III, Remote Assistant III

Applicant Biotronik, Inc.

K-Number K190548

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LLZ 2019-07-05

syngo.MR Applications

Applicant Siemens Medical Solutions USA, Inc.

K-Number K182904

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GCJ 2019-07-05

Arthrex NanoScope System

Applicant Arthrex, Inc.

K-Number K190645

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