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

OUR 2023-07-28

SI-Cure Sacroiliac Joint Fusion System

Applicant Alevio, LLC

K-Number K231951

View Details →

KOC 2023-07-28

Blood Tubing Lines for Hemodialysis AV06C-E

Applicant NIKKISO CO., LTD.

K-Number K231589

View Details →

FED 2023-07-28

Pathfinder Endoscope Overtube with Balloon Device

Applicant Neptune Medical, Inc.

K-Number K230801

View Details →

QDG 2023-07-28

FLUOBEAM® LX Red

Applicant Fluoptics Sas

K-Number K230898

View Details →

BZR 2023-07-28

FlowStar Touch Digital Mixer Flowmeter

Applicant Baldus Sedation GmbH & Co. KG

K-Number K222794

View Details →

PJD 2023-07-28

Quantisal™ II Oral Fluid Collection Device

Applicant Immunalysis Corporation

K-Number K223781

View Details →

FXX 2023-07-28

3 Layer Surgical Mask (134252531)

Applicant Original Mattress Factory, Inc.

K-Number K231618

View Details →

PEA 2023-07-28

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

Applicant Pentax of America, Inc.

K-Number K231249

View Details →

NKB 2023-07-28

Adena-Zina Spinal System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K231931

View Details →

DPS 2023-07-28

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

Applicant Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

K-Number K223670

View Details →

NDC 2023-07-28

BlueStar and BlueStar Rx

Applicant Welldoc, Inc.

K-Number K230813

View Details →

GWG 2023-07-28

HJY VisualNext Endoscopic Vision System

Applicant Hjy Smart Medical Device Co., Ltd.

K-Number K222735

View Details →

Page 831 of 2738

↑