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

MUJ 2020-09-24

RayStation

Applicant RaySearch Laboratories AB (PUBL)

K-Number K200569

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FGE 2020-09-24

EndoGI S-Path Biliary Stent System

Applicant Endo GI Medical

K-Number K202477

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OVE 2020-09-24

Cavetto-SA Cervical Cage System

Applicant Neurostructures, Inc.

K-Number K200115

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DQA 2020-09-23

Pulse Oximeter

Applicant Shenzhen Aeon Technology Co., Ltd.

K-Number K200414

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DXH 2020-09-23

Halo AF Detection System

Applicant Livmor

K-Number K201208

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GZI 2020-09-23

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K-Number K193276

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MAX 2020-09-23

FlareHawk TiHawk9 Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K201367

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MRC 2020-09-23

Boston One Step Liquid Enzymatic Cleaner

Applicant Bausch & Lomb, Incorporated

K-Number K200416

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DZE 2020-09-23

IBS Implant System

Applicant Innobiosurg Co., Ltd.

K-Number K202479

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HSB 2020-09-23

DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

Applicant Synthes (USA) Products, LLC

K-Number K201346

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HWC 2020-09-23

Responsive Arthroscopy Interference Screw System

Applicant Responsive Arthroscopy, LLC

K-Number K202569

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LZA 2020-09-22

Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs

Applicant O&M Halyard, Inc.

K-Number K200843

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