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

SGW 2025-12-23

LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

Applicant DiaSorin, Inc.

K-Number DEN250032

View Details →

IYN 2025-12-23

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

Applicant Edan Instruments, Inc.

K-Number K251268

View Details →

INI 2025-12-23

Electric Scooter (S202572J, S2060, M2089, S2050)

Applicant Guangdong Prestige Technology Co., Ltd.

K-Number K252835

View Details →

HGX 2025-12-23

Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)

Applicant Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.

K-Number K253072

View Details →

KWL 2025-12-23

OsteoRemedies Hip Spacer System

Applicant Osteoremedies, LLC

K-Number K253675

View Details →

SGX 2025-12-23

QIKCAP System

Applicant Hai Solutions

K-Number DEN250004

View Details →

MUJ 2025-12-23

ART-Plan+ (v3.1.0)

Applicant Therapanacea Sas

K-Number K253091

View Details →

OHT 2025-12-23

Philips Lumea IPL

Applicant Philips Consumer Lifestyle B.V.

K-Number K253754

View Details →

LPL 2025-12-23

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)

Applicant Bruno Vision Care, LLC

K-Number K251683

View Details →

NFO 2025-12-23

Aura Glide (FC40)

Applicant Aura Medical, LLC

K-Number K252187

View Details →

OLO 2025-12-22

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K253661

View Details →

IYN 2025-12-22

Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K252557

View Details →

Page 106 of 2685

↑