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

MQB 2019-03-08

Nexus DR Digital X-ray Imaging System

Applicant Varex Imaging Corporation

K-Number K190146

View Details →

QFM 2019-03-08

cmTriage

Applicant Curemetrix, Inc.

K-Number K183285

View Details →

GXI 2019-03-08

Rulo Radiofrequency Lesion Probe

Applicant Epimed International, Inc.

K-Number K190256

View Details →

DYB 2019-03-07

Endophys Pressure Sensing Sheath

Applicant Endophys Holdings, LLC

K-Number K190098

View Details →

LON 2019-03-07

VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)

Applicant bioMerieux, Inc.

K-Number K183551

View Details →

LXJ 2019-03-07

DARI Health

Applicant Scientific Analytics, Inc.

K-Number K180880

View Details →

DRG 2019-03-07

VitalConnect Platform, VitalPatch Biosensor

Applicant Vitalconnect, Inc.

K-Number K183078

View Details →

MQR 2019-03-07

HANAROSTENT LowAx Colon/Rectum (NNN)

Applicant M.I.Tech Co., Ltd.

K-Number K190141

View Details →

QJQ 2019-03-07

Cervella

Applicant Innovative Neurological Devices, LLC

K-Number K182311

View Details →

DRT 2019-03-07

Philips wearable biosensor-G5 Solution

Applicant Connected Sensing- A Division of Philips Medical Systems

K-Number K181165

View Details →

FOZ 2019-03-07

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K182870

View Details →

MAX 2019-03-07

Duo Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K190055

View Details →

Page 1877 of 2685

↑