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

OBP 2025-08-11

MagVenture TMS Therapy System

Applicant Tonica Elektronik A/S

K-Number K251125

View Details →

GEI 2025-08-11

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

Applicant Cnc Technologies

K-Number K252211

View Details →

SBF 2025-08-08

OptiVu Shoulder

Applicant Mr Surgical Solutions, LLC

K-Number K252170

View Details →

EBC 2025-08-08

Parkell Pit and Fissure Sealant

Applicant Parkell, Inc.

K-Number K243254

View Details →

JXG 2025-08-08

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Applicant Integra Lifesciences Production Corporation

K-Number K243531

View Details →

FAJ 2025-08-08

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K252176

View Details →

HQC 2025-08-08

MICOR 700 with Auto I/A

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K243395

View Details →

NUC 2025-08-08

Plain Water-based Lubricant

Applicant Global Protection Corp.

K-Number K243972

View Details →

OBP 2025-08-08

MagVenture TMS Therapy System

Applicant Tonica Elektronik A/S

K-Number K251119

View Details →

NUC 2025-08-08

Water-based Lubricant

Applicant Global Protection Corp.

K-Number K250142

View Details →

KTT 2025-08-08

SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Applicant Amdt Holdings, Inc.

K-Number K250472

View Details →

KNS 2025-08-08

Aqua Medical RF Vapor Ablation System

Applicant Aqua Medical, Inc.

K-Number K251226

View Details →

Page 207 of 2685

↑