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

NFO 2025-07-18

MF SC GEN2 Facial Toning System

Applicant Micro Current Technology, Inc.

K-Number K252218

View Details →

EBW 2025-07-18

ELEC ENGINE (Model: ISE-170L)

Applicant Micro-Nx Co., Ltd.

K-Number K231562

View Details →

IYN 2025-07-18

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K250999

View Details →

OBO 2025-07-18

Tomey Cornea/Anterior Segment OCT (CASIA2)

Applicant Tomey Corporation

K-Number K250553

View Details →

MBI 2025-07-18

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K251809

View Details →

PNR 2025-07-18

Profoject™ Enteral Feeding Syringe

Applicant CMT Health PTE., Ltd.

K-Number K251585

View Details →

LZO 2025-07-18

Z1 Hip System

Applicant Zimmer, Inc.

K-Number K251906

View Details →

ITH 2025-07-18

True Non-Surgical Spinal Decompression System (DRX9000-SL)

Applicant Excite Medical of Tampa Bay, LLC

K-Number K243775

View Details →

IZL 2025-07-18

INNOVISION-P5

Applicant Dk Medical Systems Co., Ltd.

K-Number K250750

View Details →

LTT 2025-07-18

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K250084

View Details →

PJA 2025-07-18

HeartFlow Analysis

Applicant HeartFlow, Inc.

K-Number K250902

View Details →

MUD 2025-07-17

Masimo O3 Regional Oximeter

Applicant Masimo Corporation

K-Number K243324

View Details →

Page 291 of 2728

↑