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

HSN 2020-07-10

Paragon 28 APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K-Number K192994

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JOW 2020-07-10

B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System

Applicant B&J Manufacturing , Ltd.

K-Number K200568

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SBF 2020-07-10

NextAR TKA Platform

Applicant Medacta Inernational SA

K-Number K193559

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DQD 2020-07-10

HD Steth

Applicant Hd Medical, Inc.

K-Number K201299

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QIH 2020-07-10

Ezra Plexo Software

Applicant Ezra Ai, Inc.

K-Number K192969

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JWH 2020-07-10

Triathlon Total KneeSystem

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K201343

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QAS 2020-07-09

Rapid LVO

Applicant Ischemaview, Inc.

K-Number K200941

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QJN 2020-07-09

ETHICON Linx Esophagus Sizing Tool

Applicant Torax Medical, Inc.

K-Number K201035

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GCJ 2020-07-09

GTK Trocars

Applicant Guangzhou T.K Medical Instrument Co., Ltd.

K-Number K193272

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NEY 2020-07-09

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

Applicant Galil Medical, Inc.

K-Number K200061

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JAK 2020-07-09

XACT Robotic System

Applicant Xact Robotics, Ltd.

K-Number K201586

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EBG 2020-07-09

GC Temp Print

Applicant GC America, Inc.

K-Number K193113

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