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

MUE 2017-10-20

Adani MammoScan

Applicant Adani

K-Number K172027

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GEX 2017-10-20

NeuroBlate System

Applicant Monteris Medical,

K-Number K172881

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GAP 2017-10-20

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K172149

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LLZ 2017-10-20

BR-FHUS Viewer 1.0

Applicant Taihao Medical, Inc.

K-Number K171709

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LSR 2017-10-20

Sofia Lyme FIA, Sofia Lyme Control Set

Applicant Quidel Corporation

K-Number K163713

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MVL 2017-10-20

GingiDent Gingival Retraction Paste

Applicant Pac-Dent International, Inc.

K-Number K162662

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PNR 2017-10-20

DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

Applicant Intervene Group Limited

K-Number K170371

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DZE 2017-10-20

TREFOIL System

Applicant Nobel Biocare AB

K-Number K172352

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DYB 2017-10-20

D'Vill Introducer

Applicant NuMED, Inc.

K-Number K171206

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KDL 2017-10-20

Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

Applicant S.A.L.F. Spa

K-Number K170150

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LLZ 2017-10-20

Quantra

Applicant Hologic, Inc.

K-Number K163623

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DRC 2017-10-20

SafeSept Transseptal Guidewire

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K170671

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