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

LZA 2018-08-10

Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green

Applicant Hartalega Sdn Bhd

K-Number K180644

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DWJ 2018-08-10

Altrix Precision Temperature Management System

Applicant Stryker Medical

K-Number K180834

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NKB 2018-08-10

Redi-Spine

Applicant Innovative Surgical Designs, Inc.

K-Number K181584

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PWJ 2018-08-10

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

Applicant ETHICON, Inc.

K-Number K181151

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NUH 2018-08-10

iStim S2 OTC Pain Relief TENS

Applicant Everyway Medical Instruments Co., Ldt.

K-Number K181849

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OAP 2018-08-10

Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup

Applicant Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

K-Number K181253

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MUD 2018-08-09

Presygen/si-1

Applicant Christie Medical Holdings, Inc.

K-Number K171245

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OMP 2018-08-09

VT - 100, VT - 200

Applicant Carilex Medical, Inc.

K-Number K173407

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MBI 2018-08-09

SECULOK Suture Anchor

Applicant U&I Corporation

K-Number K180759

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DZE 2018-08-09

MyPlant II Implant System

Applicant Hager& Meisinger GmbH

K-Number K173819

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OOE 2018-08-09

LENSAR Laser System - fs 3D (LLS-fs 3D)

Applicant Lensar, Inc.

K-Number K181430

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HRS 2018-08-09

EVOS Wrist Fracture Plating System

Applicant Smith & Nephew, Inc.

K-Number K181533

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