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

FAD 2019-05-24

Tria Firm Ureteral Stent

Applicant Boston Scientific Corporation

K-Number K190603

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KNW 2019-05-24

Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix

Applicant Bioncise NV

K-Number K190378

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GXY 2019-05-24

COMPLETE CONTROL System Gen2

Applicant Coapt, LLC

K-Number K191083

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MAX 2019-05-23

Luna 3D GEN2 Interbody Fusion System

Applicant Benvenue Medical, Inc.

K-Number K183560

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KGO 2019-05-23

Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Applicant Ansell Healthcare Products, LLC

K-Number K190018

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KRD 2019-05-23

IMPEDE-FX Embolization Plug

Applicant Shape Memory Medical

K-Number K182390

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EOQ 2019-05-23

PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus

Applicant Pentax of America, Inc.

K-Number K183654

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DQY 2019-05-23

Upstream GoBack Crossing Catheter

Applicant Upstream Peripheral Technologies, Ltd.

K-Number K182937

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QEP 2019-05-23

Aptima Combo 2 Assay (Panther System)

Applicant Hologic, Inc.

K-Number K190515

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PQA 2019-05-23

Aptima BV Assay

Applicant Hologic, Inc.

K-Number K190452

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NKB 2019-05-23

Mariner Outrigger Revision System

Applicant SeaSpine Orthopedics Corporation

K-Number K183639

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OMP 2019-05-23

Longterm NPWT Foam Dressing Kit

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K-Number K182458

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