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

PRB 2017-03-04

CINtec Histology (50 tests), CINtec Histology (250 tests)

Applicant Ventana Medical Systems, Inc.

K-Number DEN160019

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KPR 2017-03-03

DigiX FDX

Applicant Allengers Medical Systems Limited

K-Number K162529

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HEB 2017-03-03

Ontex and other proprietary names

Applicant Ontex Bvba

K-Number K162746

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OBO 2017-03-03

3D OCT-1 Maestro

Applicant Topcon Corporation

K-Number K170164

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GDW 2017-03-03

Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler

Applicant Chongqing Qmi Surgical Co., Ltd.

K-Number K162947

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EMA 2017-03-03

Glass Ionomer Cement

Applicant Shandong Huge Dental Material Corporation

K-Number K160345

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EBI 2017-03-03

Dentca Denture Base II

Applicant Dentca, Inc.

K-Number K162044

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NKG 2017-03-03

Z-LINKPC System

Applicant Zavation, LLC

K-Number K162575

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HWC 2017-03-03

ToeMATE® Hammertoe Correction System

Applicant Arthrosurface, Inc.

K-Number K170350

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JAK 2017-03-03

HITACHI Supria Whole-body X-ray CT System Phase 3

Applicant Hitachi Medical Systems America, Inc.

K-Number K163528

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KRD 2017-03-03

AZUR CX Detachable 18 Peripheral Coil System

Applicant MicroVention, Inc.

K-Number K162524

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LZA 2017-03-03

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K162646

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