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

LOD 2019-01-09

G3A 40 Bone Cement

Applicant G21, S.R.L.

K-Number K181282

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IYN 2019-01-09

DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K181637

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MQB 2019-01-09

Wireless Digital Flat Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K183713

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OVD 2019-01-09

Reliance Lumbar IBF System

Applicant Reliance Medical Systems

K-Number K181118

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MQB 2019-01-09

Wireless Digital Flat Panel Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K183422

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EOB 2019-01-09

PENTAX Medical EPK-3000 Video Imaging System

Applicant Pentax of America, Inc.

K-Number K182846

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KGO 2019-01-09

Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K181047

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EBF 2019-01-09

Fit SA

Applicant Shofu Dental Corporation

K-Number K182869

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MBI 2019-01-09

Cortical Fixation Systems

Applicant Cousin Biotech Sas

K-Number K181086

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MBI 2019-01-08

TruShot with Y-Knot Shallow All-Suture Anchor

Applicant Conmed Corporation

K-Number K182439

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NXC 2019-01-08

Park Dental Research Aligners

Applicant Park Dental Research Corporation

K-Number K180648

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IYN 2019-01-08

HS30 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K182632

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