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

LLZ 2023-01-13

MR Diffusion Perfusion Mismatch V1.0

Applicant Olea Medical

K-Number K223502

View Details →

FRO 2023-01-13

Spectricept Skin and Wound Cleanser

Applicant Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.

K-Number K213514

View Details →

GCJ 2023-01-13

Scivita 4KINSIGHT ICG Imaging System

Applicant Scivita Medical Technology Co., Ltd.

K-Number K221252

View Details →

QMJ 2023-01-13

Silkn Toothwave

Applicant Home Skinovations , Ltd.

K-Number K214078

View Details →

NCX 2023-01-13

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

Applicant Zoll Circulation, Inc.

K-Number K223746

View Details →

LZA 2023-01-13

Nitrile Exam Gloves (Chemotherapy Drug Tested)

Applicant Us Medical Glove Company, LLC

K-Number K223748

View Details →

OAS 2023-01-12

PreXion3D Expedition

Applicant Prexion Corporation

K-Number K222150

View Details →

LLZ 2023-01-12

MAMMOVISTA B.smart (VB70)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K223363

View Details →

LLZ 2023-01-12

AIBOLIT 3D+

Applicant Aibolit Technologies, LLC

K-Number K222458

View Details →

GWQ 2023-01-12

Neuronaute with IceCap 2 & IceCap 2 Small

Applicant Bioserenity

K-Number K223644

View Details →

GEI 2023-01-12

NeoGen PSR System

Applicant Energist Limited

K-Number K221873

View Details →

NHA 2023-01-12

MU System

Applicant Dentis Co., Ltd.

K-Number K222976

View Details →

Page 905 of 2685

↑