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

IYN 2019-06-12

RS85 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K191115

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OWT 2019-06-12

Phasix ST Mesh with Open Positioning System

Applicant C.R. Bard, Inc.

K-Number K190185

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PKT 2019-06-12

Eon FR

Applicant Dominion Aesthetic Technologies, Inc.

K-Number K180511

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DRG 2019-06-12

Life Sensor Cardiac Monitor

Applicant Braveheart Wireless, Inc.

K-Number K191331

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EOB 2019-06-12

PENTAX Medical ENT Video Imaging System

Applicant Pentax of America, Inc.

K-Number K183691

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MQE 2019-06-12

Wallace Dual Lumen Oocyte Recovery System

Applicant CooperSurgical, Inc.

K-Number K191291

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GAT 2019-06-11

Force Fiber Suture

Applicant Teleflex Medical Incorporated

K-Number K191268

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PNO 2019-06-11

Scoreflex PTA Scoring Balloon Catheter

Applicant Orbusneich Medical Trading, Inc.

K-Number K182713

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FRG 2019-06-11

JAMBRO Single Core A Sterilization wrap

Applicant Jiangsu Zhande Medical Supplies Co., Ltd.

K-Number K182656

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MAI 2019-06-11

Arthrex SwiveLock Suture Anchor

Applicant Arthrex, Inc.

K-Number K191226

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NKB 2019-06-11

NOVA Minimally Invasive System

Applicant Baui Biotech Co., Ltd.

K-Number K182416

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HSB 2019-06-11

T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System

Applicant Stryker Trauma GmbH

K-Number K191271

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