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

LLZ 2018-03-12

SICAT Endo

Applicant Sicat GmbH & Co. KG

K-Number K180262

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LCX 2018-03-12

Preview Digital Pregnancy Test

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K173229

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GAM 2018-03-12

REXMONO, PDREX

Applicant Sm Eng Co., Ltd.

K-Number K173779

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KNW 2018-03-12

Corvocet Biopsy System

Applicant Merit Medical Systems, Inc.

K-Number K180450

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FAD 2018-03-12

RocaJJ Soft Stents

Applicant Promepla Sam

K-Number K173734

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PGW 2018-03-10

Acclarent ENT Navigation System

Applicant Acclarent, Inc.

K-Number K173628

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OLV 2018-03-09

Grass TWin

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K173690

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FAD 2018-03-09

VORTEK URETERAL DOUBLE LOOP STENT

Applicant Coloplast Corp.

K-Number K180057

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LYZ 2018-03-09

Powder-free Clear Vinyl Patient Examination Gloves

Applicant Yongsheng Medical Products Co., Ltd.

K-Number K173078

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FTL 2018-03-09

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)

Applicant Sofradim Production

K-Number K173796

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KWT 2018-03-09

Catalyst CSR 3 Peg Glenoids

Applicant Catalyst Orthoscience, Inc.

K-Number K173812

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LLZ 2018-03-09

BrightMatter Plan 1.6.0

Applicant Synaptive Medical, Inc.

K-Number K180394

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