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

IYE 2017-10-27

SOFTDISO

Applicant Best Nomos

K-Number K170345

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FRG 2017-10-27

Tyvek Sterilization Pouches with Chevron Seal

Applicant Andersen Sterilizers, Inc.

K-Number K170429

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DXN 2017-10-27

Automatic Blood Pressure Monitor Model LD-518 & LD-537

Applicant Honsun (Nantong) Co., Ltd.

K-Number K170466

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GCJ 2017-10-27

Trocar

Applicant Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

K-Number K172038

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GEX 2017-10-27

Cutera enlighten III Laser System

Applicant Cutera, Inc.

K-Number K172077

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ODG 2017-10-27

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

Applicant Boston Scientific

K-Number K173184

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LLZ 2017-10-27

Infinitt PACS 7.0

Applicant Infinitt Healthcare Co., Ltd.

K-Number K172803

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PGY 2017-10-27

2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K172815

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DWF 2017-10-27

Tubing Pack

Applicant Medtronic, Inc.

K-Number K171979

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CDD 2017-10-27

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

Applicant Axis-Shield Diagnostics, Ltd.

K-Number K172133

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MQP 2017-10-26

Omnia Medical VBR

Applicant Omnia Medical, LLC

K-Number K172323

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GEX 2017-10-26

Rhapsody H-30 Holmium Laser System

Applicant Cook Incorporated

K-Number K172325

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