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

QNL 2024-06-21

eCARTv5 Clinical Deterioration Suite (eCART)

Applicant Agilemd, Inc.

K-Number K233253

View Details →

FXX 2024-06-21

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K232807

View Details →

ODE 2024-06-21

GERDX-System

Applicant G-Surg GmbH

K-Number K233240

View Details →

GEX 2024-06-21

MOTUS PRO Family

Applicant El.En S.P.A.

K-Number K241459

View Details →

JOW 2024-06-21

Therm-X (Home); Therm-X (AT)

Applicant Zenith Technical Innovations

K-Number K240125

View Details →

OHT 2024-06-21

Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K240649

View Details →

HHE 2024-06-21

Sunny Cup and Applicator

Applicant Menstrual Mates

K-Number K233361

View Details →

OWB 2024-06-21

O-arm O2 Imaging System

Applicant Medtronic Navigation, Inc.

K-Number K240465

View Details →

IYN 2024-06-21

V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K240631

View Details →

JOW 2024-06-21

Nimbl (model PD08-N1)

Applicant Tactile Medical

K-Number K234155

View Details →

QLQ 2024-06-21

M6-C Single Use, Disposable Instrumentation

Applicant Spinal Kinetics / Orthofix / Seaspine

K-Number K241117

View Details →

SBO 2024-06-21

PRESSUREALERT® Pressure Monitoring System

Applicant Position Health, LLC

K-Number K233096

View Details →

Page 513 of 2685

↑