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

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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NGT 2018-06-21

0.9% Sodium Chloride Injection, USP

Applicant Medline Industries, Inc.

K-Number K173348

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PHX 2018-06-21

Integra TITAN Reverse Shoulder System

Applicant Integra LifeSciences Corporation

K-Number K173717

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MQB 2018-06-21

Eclipse II

Applicant Carestream Health, Inc.

K-Number K180809

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CAF 2018-06-21

HOMED Mesh Nebulizer

Applicant Shenzhen Homed Medical Device Co., Ltd.

K-Number K170886

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FDF 2018-06-21

Pure Vu System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K181437

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FMI 2018-06-21

Kopac Sterile Needle

Applicant Poonglim Pharmatech, Inc.

K-Number K172483

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DXN 2018-06-21

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

Applicant Healthstats International Pte. , Ltd.

K-Number K173028

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