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

HWC 2022-12-29

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

Applicant Acumed, LLC

K-Number K221333

View Details →

CIG 2022-12-29

Total Bilirubin2

Applicant Abbott Ireland Diagnostics Division

K-Number K223324

View Details →

FAJ 2022-12-29

OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

Applicant Olympus Medical Systems Corp.

K-Number K221690

View Details →

NHA 2022-12-29

BioClean Implant Restorative System

Applicant Bioclean Dental, LLC

K-Number K222984

View Details →

JXG 2022-12-29

Reflow System Mini and ReFlow Mini Flusher

Applicant Anuncia Medical, Inc.

K-Number K223603

View Details →

PHL 2022-12-29

Atalante

Applicant Wandercraft SAS

K-Number K221859

View Details →

MEG 2022-12-29

SafeR Syringe and SafeR Sting

Applicant Roncadelle Operations Srl

K-Number K221981

View Details →

FGE 2022-12-29

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers

Applicant Boston Scientific Corporation

K-Number K223592

View Details →

FKX 2022-12-29

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

Applicant Iren-Medical, Ltd.

K-Number K220935

View Details →

BSK 2022-12-29

AG100s

Applicant Hospitech Respiration , Ltd.

K-Number K221477

View Details →

GEX 2022-12-29

CLEAR+BRILLIANT TOUCH® Laser System

Applicant Solta Medical, Inc.

K-Number K223647

View Details →

KPI 2022-12-29

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode

Applicant Well-Life Healthcare Limited

K-Number K222528

View Details →

Page 912 of 2685

↑