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

GEX 2025-10-03

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

Applicant Jeisys Medical Incorporated

K-Number K251464

View Details →

LRK 2025-10-03

Anti Snore Mouthpiece

Applicant Dongguan Yiyao Science & Technology Development Co., Ltd.

K-Number K250028

View Details →

GEX 2025-10-03

HESTIA (L200-A)

Applicant Senbitec Co., Ltd.

K-Number K242946

View Details →

DQX 2025-10-03

Amplatzer Guidewire

Applicant ABBOTT MEDICAL

K-Number K250031

View Details →

IOR 2025-10-03

Manual Wheelchair (SYIV100A008)

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K252517

View Details →

EZD 2025-10-03

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)

Applicant Hollister Incorporated

K-Number K251468

View Details →

PKC 2025-10-03

AETOS Shoulder System Stemless Humeral Prosthesis

Applicant Smith & Nephew, Inc.

K-Number K252129

View Details →

JAK 2025-10-03

Bunkerhill MAC

Applicant BunkerHill Health

K-Number K250662

View Details →

FJK 2025-10-02

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Applicant Ningbo Tianyi Medical Appliance Co., Ltd.

K-Number K251442

View Details →

OHT 2025-10-02

IPL Hair Removal Device (IPL-001, IPL-002)

Applicant Shenzhen Enmind Technology Co., Ltd.

K-Number K251398

View Details →

JWY 2025-10-02

MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Applicant Liofilchem s.r.l.

K-Number K252114

View Details →

KLE 2025-10-02

G-Bond Universal

Applicant GC America, Inc.

K-Number K251124

View Details →

Page 167 of 2685

↑