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

JAA 2025-09-16

Insight Enhanced™ DRF (EN-1002-01)

Applicant Imaging Engineering, LLC

K-Number K251650

View Details →

OHT 2025-09-15

IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)

Applicant Miley Technology (Hebei) Co., Ltd.

K-Number K251914

View Details →

FAJ 2025-09-15

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K252598

View Details →

EGS 2025-09-15

Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

Applicant Premium Plus (Dongguan) Limited

K-Number K251869

View Details →

FRA 2025-09-15

Zener® (model ZEN-001-B1)

Applicant Uvx, Inc.

K-Number K252128

View Details →

DIC 2025-09-15

Sober Self-Test

Applicant Sober Ip, LLC

K-Number K250609

View Details →

OLO 2025-09-15

iGPS Navigation Instruments

Applicant SI-BONE, Inc.

K-Number K251780

View Details →

QIH 2025-09-15

InferOperate Suite

Applicant Beijing Infervision Healthcare Medical Technology Co., Ltd.

K-Number K250237

View Details →

MBB 2025-09-15

SpaceFix Shoulder Spacer

Applicant G21, S.R.L.

K-Number K252443

View Details →

OBP 2025-09-14

CloudTMS Edge

Applicant Teleemg, LLC

K-Number K250689

View Details →

OBP 2025-09-13

BrainsWay Deep TMS System

Applicant Brainsway , Ltd.

K-Number K251449

View Details →

QNP 2025-09-12

CADDIE

Applicant Odin Medical Limited

K-Number K252586

View Details →

Page 304 of 14156

↑