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

JAQ 2019-07-08

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device

Applicant Varian Medical Systems, Inc.

K-Number K191580

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MUJ 2019-07-08

RayCare 2.3

Applicant RaySearch Laboratories AB (PUBL)

K-Number K191384

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OWB 2019-07-08

nView system 1

Applicant Nview Medical, Inc.

K-Number K190064

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FLE 2019-07-08

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves

Applicant Tuttnauer , Ltd.

K-Number K181456

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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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