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

LZC 2020-09-18

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Medline Industires, Inc.

K-Number K201390

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OSP 2020-09-18

LaborView™ LV1000 Wireless Electrode System

Applicant Obmedical Company

K-Number K190798

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JWH 2020-09-18

GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)

Applicant Medacta International S.A.

K-Number K202022

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FPA 2020-09-18

Intellifuse Administration and Intellifuse Blood Administration Sets

Applicant Smiths Medical Asd, Inc.

K-Number K192375

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LLZ 2020-09-18

EchoPAC Software Only, EchoPAC Plug-In

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K200852

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KTT 2020-09-18

Smart Correction System

Applicant Wishbone Medical, Inc.

K-Number K193368

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LPL 2020-09-18

Optixon 1-Day

Applicant Optixon, Inc.

K-Number K201013

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KWQ 2020-09-17

STRUXXURE®-L and STRUXXURE®-A Plate System

Applicant Nexxt Spine, LLC

K-Number K202192

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OTN 2020-09-17

GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide

Applicant ETHICON, Inc.

K-Number K201686

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DJG 2020-09-17

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

Applicant Advin Biotech, Inc.

K-Number K201494

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QBD 2020-09-17

eNAT molecular collection and preservation medium

Applicant Copan Italia Spa

K-Number K201849

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NGX 2020-09-17

Portable Electro-Stimulation Therapy Device

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K182020

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