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

GEX 2020-03-16

Epic 980

Applicant Biolase, Inc.

K-Number K193486

View Details →

NFJ 2020-03-16

CONTINUUM PACS

Applicant Integrated Ophthalmic Systems, Inc.

K-Number K200385

View Details →

GEX 2020-03-16

SANDRO Dual

Applicant Wontech Co., Ltd.

K-Number K200110

View Details →

LLZ 2020-03-16

AnatomicAligner

Applicant The Methodist Hospital Research Institute D/B/A Houston

K-Number K190767

View Details →

DXC 2020-03-16

Sunmed Disposable Angio-Closure Pads

Applicant Sunny Medical Device (Shenzhen) Co., Ltd.

K-Number K191827

View Details →

FYA 2020-03-16

AERO CHROME* Breathable Performance Surgical Gowns

Applicant O&M Halyard, Inc.

K-Number K200522

View Details →

OWI 2020-03-16

Response BandLoc Spinal Fixation

Applicant OrthoPediatrics Corp.

K-Number K200097

View Details →

JAK 2020-03-16

Al-Rad Companion (Musculoskeletal)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193267

View Details →

CAH 2020-03-16

Altera Filter and HME/Filter

Applicant Meditera Tibbi Malzeme San VE Tic AS

K-Number K192713

View Details →

DDG 2020-03-16

Transferrin

Applicant Biosystems S.A.

K-Number K190495

View Details →

NUH 2020-03-14

Health Expert Electronic Stimulator (model: AST-300L)

Applicant Shenzhen Osto Technology Company Limited

K-Number K190783

View Details →

GXR 2020-03-13

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

Applicant Neurovention, LLC

K-Number K192162

View Details →

Page 1625 of 2685

↑