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

MAI 2018-06-22

Knotless SutureTak Anchors

Applicant Arthrex, Inc.

K-Number K180594

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DRT 2018-06-22

Vios Monitoring System™ Model 2050

Applicant Vios Medical, Inc.

K-Number K172586

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DZE 2018-06-22

MIS Internal Hex Dental Implant System

Applicant Mis Implants Technologies , Ltd.

K-Number K180282

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JOW 2018-06-22

AIROS 6 Sequential Compression Device

Applicant Airos Medical, Inc.

K-Number K172770

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GCA 2018-06-22

Advance Biliary Balloon Catheter

Applicant Cook Incorporated

K-Number K173414

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HBC 2018-06-22

OSSEODUO Shaver and Drill System

Applicant Bien-Air Surgery SA

K-Number K173066

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DYB 2018-06-22

iSLEEVE Introducer Set

Applicant Boston Scientific Corporation

K-Number K180785

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QSY 2018-06-22

gel-e Flex

Applicant Gel-E, Inc.

K-Number K180152

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MRG 2018-06-22

BioPlex 2200 25-OH Vitamin D Kit

Applicant Bio-Rad Laboratories

K-Number K180577

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LLZ 2018-06-22

MIM - SPECTRA Quant

Applicant Mim Software, Inc.

K-Number K180815

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GEI 2018-06-21

LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated

Applicant Covidien

K-Number K181085

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JDQ 2018-06-21

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional

Applicant Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K-Number K172975

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