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

OMP 2025-02-18

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

Applicant Smith & Nephew Medical, Ltd.

K-Number K243576

View Details →

LZA 2025-02-18

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

Applicant Basic Medical Technology, Inc.

K-Number K243792

View Details →

JWH 2025-02-18

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

Applicant Microport Orthopedics, Inc.

K-Number K243574

View Details →

ODP 2025-02-18

FIX-C 3D Ti ACIF System

Applicant Jeil Medical Corporation

K-Number K243915

View Details →

HIS 2025-02-18

0.04 ZERO ZERO FOUR Male Latex Condom

Applicant Okamoto USA, Inc.

K-Number K243584

View Details →

POM 2025-02-15

Sway System Sports Plus

Applicant Sway Medical, Inc.

K-Number K241737

View Details →

OHS 2025-02-14

CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K242593

View Details →

QOF 2025-02-14

Alinity m Resp-4-Plex

Applicant Abbott Molecular, Inc.

K-Number K241573

View Details →

GWN 2025-02-14

ICS Dizcovery (1091)

Applicant Natus Medical Denmark Aps

K-Number K242198

View Details →

FLL 2025-02-14

Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)

Applicant Shenzhen Finicare Co., Ltd.

K-Number K243136

View Details →

OAS 2025-02-14

Green X 21 (PHT-90CHO)

Applicant VATECH Co., Ltd.

K-Number K243081

View Details →

MRH 2025-02-14

VIA360 Surgical System

Applicant New World Medical, Inc.

K-Number K243503

View Details →

Page 340 of 2685

↑