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

DZE 2019-05-24

Conical Plus Implant System

Applicant Osseofuse International, Inc.

K-Number K181157

View Details →

LYZ 2019-05-24

Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Jiangxi Jaysun Medcare Co., Ltd.

K-Number K182575

View Details →

HWC 2019-05-24

InCore® Lapidus Sterile Kits

Applicant Nextremity Solutions, Inc.

K-Number K190231

View Details →

LZO 2019-05-24

MobileLink Acetabular Cup System

Applicant Waldemar Link GmbH & Co. KG

K-Number K182321

View Details →

ODW 2019-05-24

TruDiagnosis System

Applicant Akonni Biosystems, Inc.

K-Number K183530

View Details →

FAD 2019-05-24

Tria Firm Ureteral Stent

Applicant Boston Scientific Corporation

K-Number K190603

View Details →

KNW 2019-05-24

Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix

Applicant Bioncise NV

K-Number K190378

View Details →

GXY 2019-05-24

COMPLETE CONTROL System Gen2

Applicant Coapt, LLC

K-Number K191083

View Details →

MAX 2019-05-23

Luna 3D GEN2 Interbody Fusion System

Applicant Benvenue Medical, Inc.

K-Number K183560

View Details →

KGO 2019-05-23

Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Applicant Ansell Healthcare Products, LLC

K-Number K190018

View Details →

KRD 2019-05-23

IMPEDE-FX Embolization Plug

Applicant Shape Memory Medical

K-Number K182390

View Details →

EOQ 2019-05-23

PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus

Applicant Pentax of America, Inc.

K-Number K183654

View Details →

Page 1825 of 2685

↑