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

EOQ 2025-08-27

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K251752

View Details →

QOF 2025-08-27

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

Applicant QIAGEN GmbH

K-Number K250080

View Details →

DXF 2025-08-27

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

Applicant Atraverse Medical, Inc.

K-Number K252419

View Details →

CAW 2025-08-27

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))

Applicant Nanjing Yinuoji Medical Technology Co., Ltd.

K-Number K250625

View Details →

HRX 2025-08-27

ELID (Endoscopic Less Invasive Decompression) System

Applicant Lesspine Innovations

K-Number K243774

View Details →

HWC 2025-08-27

Phoenix Sinus Tarsi Stent System

Applicant Astra Orthomed, Inc.

K-Number K251382

View Details →

MQL 2025-08-27

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K-Number K251637

View Details →

MWI 2025-08-27

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

Applicant Fysicon BV

K-Number K241766

View Details →

QIH 2025-08-27

VistaSoft 4.0 and VisionX 4.0

Applicant Durr Dental SE

K-Number K250947

View Details →

HGM 2025-08-27

Fetal & Maternal Monitor (F15A, F15A Air)

Applicant Edan Instruments, Inc.

K-Number K241882

View Details →

FRO 2025-08-27

Dermalage

Applicant Infection Elimination Solutions, LLC

K-Number K243166

View Details →

QME 2025-08-27

Vital Signs

Applicant Oxehealth Limited

K-Number K243687

View Details →

Page 195 of 2685

↑